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Pediatric Trials 
TITLE ACCL 0331: A Randomized Double Blind Placebo Controlled Trial to Assess the Efficacy of Traumeel S for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
DESCRIPTION This study will determine if Traumeel® S can prevent and treat mouth sores (mucositis) and/or lessen the pain and discomfort of existing mouth sores in patients having stem cell transplantation. Traumeel® S is a natural medicine made from several plants and minerals. Patients will be randomly chosen to be given either a mouth rinse with the Traumeel® S treatment or a placebo mouth rinse. Patients will be asked to rinse their mouths or hold the solution in their mouths for thirty seconds and then swallow it. Treatment will start the day before the transplant and stop on Day #20 (this would be equal to of 22 days of treatment with Traumeel® S ), or when the mouth sores are gone, but no earlier than Day #12 (this would be equal to 14 days of Traumeel® S treatment). 
ELIGIBILITY
  1. Can be undergoing allogenic, or autologous hematopoietic stem cell transplant with source of stem cells being bone marrow, placenta blood or cytokine mobilized peripheral blood; receiving any type of GVHD prophylaxis; patients receiving any type of myeloablative stem cell transplant conditioning regimen (patients receiving non-myeloablative chemotherapy are excluded)
  2. Must be between 3 and 25 years old
  3. Cannot be receiving oral vancomycin paste or glutamine as an oral supplement
  4. Cannot have a known allergy to Echinacea
CONTACT Kay Krimmel 216-844-3999
TITLE ACNS 0423: A Phase II Study of Concurrent Radiation and Temozolomide Followed by Temozolomide and Lomustine (CCNU) in the Treatment of Children with High Grade Glioma
DESCRIPTION This study will determine if treatment with temozolomide and radiation, followed by treatment with a combination of temzolomide and Lomustine (CCNU) for 9 months after radiation therapy, works better than the standard treatment in children with a type of brain tumor called a high-grade glioma. In the first part of the treatment, radiation therapy will be directed to the brain, 5 days a week for 6 weeks. Patients will be given the drug Temozolomide by mouth for 42 days (6 weeks). A four-week rest period will follow. The second part of the treatment, called Maintenance, begins at the end of the rest period. No further radiation will be given but the drug Temozolomide will be given by mouth for five days in a row followed by a 37 day break. Another chemotherapy drug known as Lomustine (CCNU) will also be given by mouth along with the temzolomide on day 1. This 42-day cycle will be repeated 6 times. Overall, the treatment portion of the study will last for about 11-12 months. 
ELIGIBILITY
  1. Must have newly diagnosed CNS tumor: anaplastic astrocytoma, glioblastoma multiforme or gliosarcoma, with histological verification of disease
  2. Must begin therapy within 31 days of surgery
  3. Must have a pre-operative and post-operative brain MRI with and without contrast (requirement for post-operative MRI is waived for patients who undergo biopsy only)
  4. Must be 3 years of age or older but less than 22 years of age at time of enrollment
  5. Cannot have received any prior treatment other than surgery or corticosteroids
  6. Must have adequate bone marrow, kidney, liver and CNS function if seizures are well controlled
  7. Must be able to swallow medications
  8. Must have performance level of ≥ 50% (Karnofsky) for patients > 16 years of age, and ≥ 50 (Lansky) for patients ≤ 16 years of age

    Must have life expectancy eight weeks or greater
CONTACT Kay Krimmel 216-844-3999
TITLE ADVL 0421: A Phase II Study of Oxaliplatin in Children with Recurrent Solid Tumors 
DESCRIPTION This study will determine how well the drug oxaliplatin works in patients with solid tumors. It will also determine what kinds of tumors oxaliplatin works against, whether oxaliplatin given alone will work to shrink tumors and how the body handles and gets rid of the drug. Oxaliplatin will be given as an intravenous infusion on the first day of every three-week period. 
ELIGIBILITY
  1. Must have been diagnosed with any of the following tumors: Ewing sarcoma or peripheral PNET, osteosarcoma, rhabdomyosarcoma, neuroblastoma, high grade astrocytoma and multiforme glioblastoma, low grade astrocytoma, brain stem glioma, ependymoma, hepatoblastoma, malignant germ cell tumors of any site, other rare tumors of interest – soft tissue sarcoma, hepatocellular carcinoma, childhood/adolescent colorectal carcinoma, renal cell carcinoma, adrenocortical carcinoma and nasopharyngeal carcinoma
  2. Must have been no greater than 21 years of age inclusive when originally diagnosed with the malignancy
  3. Must have measurable disease and histological verification of the malignancy
  4. Must have performance level of ≥ 50% (Karnofsky) for patients > 10 years of age, and ≥ 50 (Lansky) for patients ≤ 10 years of age
  5. Must have life expectancy of ≥ 8 weeks
  6. Must be fully recovered from all acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering the study
  7. Must have adequate bone marrow, kidney, liver, and central nervous system (CNS) function
  8. Cannot have had prior oxaliplatin exposure or be receiving other anti-cancer agents or another investigational drug
  9. Cannot have an uncontrolled infection
CONTACT Kay Krimmel 216-844-3999
TITLE AEWS 02P1: A Pilot Study of Low Dose Antiangiogenic Chemotherapy in Combination with Standard Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma Family of Tumor
DESCRIPTION This study will determine the effects of a drug combination (vinblastine and celecoxib) given along with the standard care for treatment of a type of cancers called Ewing Sarcoma Family of Tumors (ESFT). This study will evaluate whether these drugs help stop the growth of ESFT by blocking or destroying the blood vessels that feed the tumor so the tumor cannot grow as well. Some patients on the study will be evaluated to see if special diagnostic scans can be used to determine how the tumor is responding to the treatment and to predict long term outcome. Celecoxib will be given as a pill, twice a day beginning on the first day of Cycle 1 and continuing through Day 21 of Cycle 14. Vinblastine will be given intravenously (by vein) three times a week beginning on Day 1 of Cycle 1 and continuing through Day 21 of Cycle 14. 
ELIGIBILITY
  1. Patients with a newly diagnosed metastatic Ewing sarcoma family of tumors of bone or soft tissues excluding the central nervous system. Paraspinal tumors of extra-dural origin and Askin’s tumor of the chest wall are eligible.
  2. Must be 50 years of age or less at diagnosis; there is no minimum age but patients must have a body surface area (BSA) of at least 0.4 m2
  3. Must have performance level Lansky score ≥ 50% for patients less than 17 years of age; patients; 17 years of age or older must have a Karnofsky score ≥ 50%. (Patients whose performance status is adversely affected by a pathological fracture but who are able to undergo treatment will be eligible)
  4. Must have no prior history of cancer (including non-melanoma skin cancer) and may not have received chemotherapy, radiation, or a bone marrow/stem cell transplant
  5. Must stop taking non-steroidal anti-inflammatory medications, once study treatment has begun
  6. Must have adequate kidney, liver, and cardiac function
CONTACT Kay Krimmel 216-844-3999
TITLE ARST 0331: Vincristine, Dactinomycin and Lower Doses of Cyclophosphamide with or without Radiation Therapy for Patients with Newly Diagnosed Low Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
DESCRIPTION This study is being done to determine the most treatment with the least amount of therapy that will effectively treat patients with low risk rhabdomyosarcoma (or the related types, botryoid or spindle cell rhabdomyosarcoma or embryonal ectomesenchymoma). Patients enrolling on this study will be divided into groups (called Subsets 1 or 2), based upon where the tumor is located, its size, whether the tumor has spread to lymph nodes, and whether the tumor can be taken out with surgery. Patients in Subset 1 will be evaluated to find out if a lower amount of cyclophosphamide (along with standard amounts of vincristine and dactinomycin) for a shorter period of time than is usually given, affects the length of time until the cancer returns. Patients in Subset 2 will be evaluated to find out if a lower amount of cyclophosphamide (along with standard amounts of vincristine and dactinomycin) affects the length of time until the cancer returns, and to find out if this treatment causes fewer effects later in life. Another difference between being treated on Subset 1 and Subset 2 is that patients in Subset 2 receive 8 more cycles of chemotherapy than the patients in Subset 1. Drugs on this study will be given by needle intravenously (by needle into a vein). The doctor will likely recommend having a central venous line (or catheter) placed into a large vein in the chest by a surgeon during a short operation so that the drugs can be given. 
ELIGIBILITY
  1. Patients with newly diagnosed embryonal rhabdomyosarcoma, botryoid or spindle cell variants of embryoanl rhabdomyosarcoma or embryonal ectomesenchymoma
  2. Must be less than 50 years old at time of enrollment
  3. Must have performance status of 0, 1, or 2
  4. Cannot have received prior chemotherapy, excluding steroids, or radiation therapy, except for patients transferring from the intermediate risk study
  5. Must have adequate kidney function (age dependent), and adequate liver and bone marrow function
  6. Must start treatment within 42 days of initial surgical procedure (including biopsy that provided the definitive diagnosis
  7. Must have no evidence of uncontrolled infection
  8. Must be able to undergo radiation therapy
CONTACT Kay Krimmel 216-844-3999
TITLE AAML 00P2 A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined with Conventional Chemotherapy for Patients with Relapsed Refractory or Second Acute Myeloid Leukemia
DESCRIPTION This study is being done to evaluate the safety and determine the maximum tolerated dose (MTD) of gemtuzumab ozogamicin (GMTZ) in combination with conventional chemotherapy in patients with relapsed, refractory or secondary acute myeloid leukemia (AML). Patients will be randomized into one of 2 treatment regimens or arms. Patients in Arm A will receive one course of gemtuzumab ozogamicin, cytarabine, and mitoxantrone. Induction will last for 56 days or until treatment response can be determined, whichever occurs first. Arm B of the study consists of a cycle of high dose cytarabine on days 1 and 2 (cycle 1), a dose of L-Asparaginase on day 2, single dose of gemtuzumab ozogamicin on day 3, and another cycle of high-dose cytarabine on days 8 and 9 (cycle 2), and a dose of L-Asparaginase on day 9. Induction will last for 56 days or until treatment response can be determined, whichever occurs first.
ELIGIBILITY
  1. Patients with primary acute myeloid leukemia or myelodysplastic syndrome must have relapsed remission duration of less than one year or have failed to achieve an initial complete response.
  2. Patients must have an M2 or M3 bone marrow aspirate at study entry.
  3. Patients with acute myeloid leukemia as a secondary cancer are also eligible provided they have had no other therapy for acute myeloid leukemia.
  4. Patients may not be older than 21 years of age at the time of entry into the study.
  5. Patients must have adequate kidney, liver and cardiac function.
CONTACT Kay Krimmel 216-844-3999
TITLE AHOD 0321 A Phase II Study of Weekly Gemcitabine and Vinorelbine in Children with Recurrent or Refractory Hodgkin's Disease
DESCRIPTION This study is being done to determine the response rate after weekly administration of the combination of gemcitabine and vinorelbine to patients with recurrent or refractory Hodgkin’s Disease. Each 21 day treatment cycle will consist of two weekly doses of gemcitabine and vinorelbine. Treatment response will be evaluated every two cycle; however, patients with any response after the first 2cycles may elect to proceed directly to stem cell transplantation. Those patients with stable disease after the first two cycles will receive a minimum of 2 more cycles of gemcitabine and vinorelbine. At the end of the 4th cycle patients without progressive disease can remain on study and continue to receive the drugs or go off study for alternative therapy. Patients may continue treatment with gemcitabine and vinorelbine on study for up to 1 year from enrollment in the study. 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of recurrent or refractory Hodgkin’s disease according to study criteria.
  2. Patients must be no greater than 30 years of age at the time of enrollment into the study.
  3. Patients must have a life expectancy of more than 8 weeks.
  4. Patients may have received a minimum of two prior cytotoxic chemotherapy regimens as well as patients who have undergone autologous or allogeneic stem cell transplantation.
  5. Patients must have fully recovered form the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy to enter the study.
  6. Patients must have adequate bone marrow, kidney, liver, pulmonary and central nervous system function.
CONTACT Kay Krimmel 216-844-3999
TITLE ANBL 0032 Phase III Randomized Study of Chimeric Anti-GD2 in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
DESCRIPTION This study is being done to determine if monoclonal antibody Ch14.18 + cytokines + isotretinoin (13-cis-retinoic acid or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone in high risk patients with neuroblastoma who have achieved a pre-ASCT response of CR, VGPR, or PR. Patients will be randomized into one of two treatment arms (Regimen A or Regimen B). Patients in Regimen A will receive the drug cis-RA approximately 2 months following stem cell transplant. 
Patients begin 6 monthly treatments with 13-cis-retinoic acid and will take this drug by mouth twice a day for 14 days and then not take it for the following 14 days. This 28-day course will be repeated 6 times. Regimen B involves treatment with cis-RA as well as the experimental agent, C14.18, GM-CSF, and IL-2. Regimen B is given over six 28-day courses; there may be different combinations of drugs in the courses.
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of neuroblastoma, and categorized as high risk at the time of diagnosis.
  2. Patients must not be older than 30 at diagnosis.
  3. If patient is enrolled in study A3973, then the patient must have completed front-line therapy followed by ASCT and radiotherapy as outlined in A3973, AND have achieved CR, VGPR or PR at pre-ASCT evaluation.
  4. If a patient is not enrolled on the study A3973, the patient will be eligible for this study if they are CR/VGPR/PR after treatment with one of the study designated induction regimens prior to a single cycle of high-dose therapy and ASCT.
  5. No later than 9 months from the date of starting the first induction chemotherapy after diagnosis to the date of autologous stem cell transplantation should elapse.
  6. Patients must not have progressive disease or biopsy proven residual disease if not enrolled on the study A3973 at the time of enrollment in this study.
  7. Patients must have adequate renal, liver, cardiac, pulmonary and central nervous function.
CONTACT Kay Krimmel 216-844-3999
TITLE ARST0121: A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination with Vincristine and Pilot Assessment of Safety and Efficacy of Tirapazamine Combined with Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors
DESCRIPTION This study will test risk-based clinical hypotheses in all patients experiencing their first relapse or progression of disease. Patients with unfavorable risk and with measurable disease are randomized to receive one of two different schedules of irinotecan in combination with vincristine. For patients with an unfavorable risk without measurable disease, or for those with prior exposure to irinotecan, tirapazamine will be added to doxorubicin and cyclophosphamide combination chemotherapy followed by ifosfamide and etoposide. Patients with relatively favorable risk will receive doxorubicin, cyclophosphamide followed by ifosfamide and etoposide.
ELIGIBILITY
  1. Biopsy proven rhabdomyosarcoma, undifferentiated sarcoma or ectomesenchymoma at first relapse or first occurrence of disease progression.
  2. Patients who have undergone prior stem cell transplant are not eligible.
  3. Patients must have adequate bone marrow, kidney, liver, heart and neurologic function.
  4. Must have a performance status of 50-100.
  5. Must not have disease impinging on or within the brain or spinal cord.
  6. Must not have a history of ischemic heart disease.
  7. Age less than 21 years of age at time of initial diagnosis of rhabdomyosarcoma, undifferentiated sarcoma or ectomesenchymoma
CONTACT Kay Krimmel 216-844-3999
 
TITLE ANHL0131: A Phase III Trial of Treatment of Advanced Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine versus Consolidation with a Regimen including Vinblastine
DESCRIPTION This study will compare a consolidation regimen including vinblastine to the standard APO regimen in the treatment of children with advanced stage anaplastic large cell lymphoma. Patients will be randomized to receive standard chemotherapy that includes doxorubicin, prednisone, and vincristine (APO) or chemotherapy including weekly vinblastine during consolidation.
ELIGIBILITY
  1. Patients with newly diagnosed CD30+ anaplastic large cell lymphoma, Murphy Stage III and IV. Patients who have received limited dose radiation therapy or steroids for management of a mediastinal mass will still be eligible for randomization.
  2. Patients with disease limited to the skin or B-cell large cell lymphoma are not eligible. 
  3. Patients must have adequate liver and heart function.
  4. Performance status will not be used to exclude any patients.
  5. Patients must be less than 21 years of age.
CONTACT Kay Krimmel 216-844-3999
 
TITLE ARST0321: A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy
DESCRIPTION This study will determine the progression free survival in children with desmoid tumor treated with sulindac and tamoxifen. Tamoxifen and sulindac are given twice daily for up to one year.
ELIGIBILITY
  1. Must have biopsy proven desmoid tumor at first presentation or any recurrence. Patients with newly diagnosed desmoid tumor are eligible if (a) they have had no prior therapy and (b) they have disease for which complete surgical resection and/or radiation therapy is not feasible. After attempted surgical resection, patients are only eligible if there is gross residual disease than can be measured on MRI scan. Patients with recurrent desmoid tumor are eligible if (a) they have radiographically documented recurrent or progressive disease, (b) prior anti-tumor therapy has not included treatment with non-steroidal anti-inflammatory drugs or estrogen antagonists, and (c) they have had no chemotherapy or radiation therapy for the present recurrence.
  2. Must have measurable disease.
  3. Patients must have adequate bone marrow, kidney, liver and heart function.
  4. Must have a Lansky/Karnofsky performance status of 50-100.
  5. Must not have a history of peptic ulcer disease, significant gastrointestinal hemorrhage, deep vein thrombosis, aspirin allergy, diagnosis of hemophilia, von Willebrand’s disease or other clinically significant bleeding diathesis.
  6. Must be no greater than 18 years of age.
CONTACT Kay Krimmel 216-844-3999
 
TITLE AGCT0132: A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors
DESCRIPTION The goal of this study is to eliminate chemotherapy for low risk patients and to decrease cumulative chemotherapy doses and treatment days for intermediate risk patients and patients with gonadal Stage I who recur as Stage I-IV with malignant germ cell tumor. Low risk patients will be monitored by tumor markers and will receive chemotherapy if there is recurrence of tumor or if tumor markers do not normalize after surgery. Intermediate risk patients will receive cisplatin, etoposide and bleomycin chemotherapy. Intermediate risk patients who achieve a complete remission after 3 cycles will discontinue chemotherapy. Intermediate risk and relapsed low risk patients who achieve a partial remission will receive 6 cycles of chemotherapy.
ELIGIBILITY
  1. Primary extracranial germ cell tumors, which are histologically verified to be yolk sac tumor, embryonal carcinoma, choriocarcinoma or teratoma with malignant elements are eligible. 
  2. Stage I-IV malignant testicular germ cell tumors or Stage I-III malignant ovarian germ cell tumors or Stage I-II malignant extragonadal germ cell tumors.
  3. No previous chemotherapy or radiation therapy.
  4. Patients must be 21 years of age or less at diagnosis, except patients with testicular primary tumors, who must be less than 15 years of age.
CONTACT Kay Krimmel 216-844-3999
 
TITLE AHOD0121: A Phase II/III Study of Immunomodulation after High Dose Myeloablative Therapy with Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin’s Disease
DESCRIPTION This study will determine the toxicity and feasibility of administering cyclosporine, interferon-gamma, and interleukin-2 following BEAM chemotherapy with autologous stem cell rescue. 
ELIGIBILITY
  1. Patients must have Hodgkin’s disease which has relapsed or become refractory to conventional therapy. Stage IA/IIA patients with nodal disease previously treated with radiation only or less than 3 courses of standard dose chemotherapy are not eligible. Measurable disease is not required. 
  2. Should be enrolled concurrently on the current COG salvage chemotherapy trial for recurrent/refractory Hodgkin’s disease. For patients ineligible for a COG salvage chemotherapy trial, salvage induction chemotherapy with ifosfamide and vinorelbine is recommended. Patients who have been treated on other appropriate salvage therapy may be enrolled only with the permission of the Study Chair.
  3. Patients must have adequate bone marrow, kidney, liver, lung and heart function.
  4. Must have a Lansky/Karnofsky performance status of 50-100.
  5. Must be less than 30 years of age
CONTACT Kay Krimmel 216-844-3999
 
TITLE ACNS0126: A Phase II Study of Temozolomide in the Treatment of Children with High Grade Glioma or Diffuse Intrinsic Pontine Gliomas
DESCRIPTION This trial will determine whether temozolomide given during radiation therapy and as adjuvant therapy results in an improvement in event-free survival compared to historical control cohorts. Temozolomide will be given concurrently with radiation therapy on a 42 day schedule. Four weeks following completion of radiation therapy, the patient will receive temozolomide daily for 5 days beginning a new cycle every 28 days for a total of 10 cycles.
ELIGIBILITY
  1. Patients must be > 3 years and < 22 years at the time of enrollment.
  2. Patients must have a newly diagnosed CNS tumor as: anaplastic astrocytoma, glioblastoma multiforme or gliosarcoma. Patients with diffuse intrinsic pontine glioma or spinal cord malignant glioma are eligible. Patients with evidence of neuraxis dissemination by spinal MRI or metastatic disease are not eligible.
  3. Must be newly diagnosed and previously untreated for current diagnosis.
  4. Patients must have adequate bone marrow, kidney, liver and neurologic function.
  5. Must have a Lansky/Karnofsky performance status of 50-100.
CONTACT Kay Krimmel 216-844-3999
 
TITLE ANHL 0121 A phase II Study of Rituximab and ICE Chemotherapy in Children with Recurrent/Refractory B-cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia
DESCRIPTION This study will determine the response and relapse-free survival rates to chemotherapy with ifosfamide, carboplatin, and etoposide (ICE) plus Rituximab for patients with recurrent/refractory CD20+ NHL and B-cell ALL. Patients will receive ICE plus Rituximab for one to three cycles depending upon evaluations of disease status following each cycle. The planned duration of each treatment cycle is 23 days.
ELIGIBILITY
  1. Patients must have recurrent or refractory CD20+ NHL or B-cell ALL. CD20 positivity must be confirmed by either flow cytometry of tumor tissue or involved marrow or by CD20 immunostaining.
  2. Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria, and be in first or later recurrence or have disease that is primary refractory to conventional therapy.
  3. Patients must have a life expectancy of greater than or equal to 2 months.
  4. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  5. Patients must have normal bone marrow, liver and kidney function.
CONTACT Kay Krimmel 216-844-3999
TITLE AHOD0031: A Phase III Group-Wide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease
DESCRIPTION This study will compare response-based therapy to standard therapy for intermediate risk Hodgkin disease. Patients will be randomized to either standard therapy or experimental therapy. All patients begin treatment on this study with two 21-day cycles of ABVE-PC chemotherapy. Patients will then be evaluated for their response to treatment and based on their response they will be randomized to receive either standard chemotherapy with ABVE-PC plus radiation therapy or CEDA plus ABVE-PC plus radiation therapy.
ELIGIBILITY
  1. Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol.
  2. Patients must have stage IB, IIB, IA (with bulk disease), Stage IIA (with bulk disease), stage IIAE, Stage IIIA, IIIAE, IIIAS, IIIAE+S or stage IVA disease.
  3. Patients may not have received any previous chemotherapy or radiation therapy.
  4. Patients must have normal kidney, liver, heart and lung function.
CONTACT Kay Krimmel 216-844-3999
TITLE AAML0122: Phase II Window Evaluation of the Farnesyl Transferase Inhibitor (R115777) Followed by 13-Cis Retinoic Acid, Cytosine Arabinoside and Fludarabine plus Hematopoietic Stem Cell Transplantation in Children with Juvenile Myelomonocytic Leukemia
DESCRIPTION This study will estimate the rate of response and define acute toxicity of the Farnesyl transferase inhibitor (R115777) used in an up-front phase II window in newly diagnosed juvenile myelomonocytic leukemia (JMML). The first phase of this study is called window therapy because patients can choose not to participate in this phase of the study. Patients who choose to participate in the window phase will receive Farnesyl Transferase Inhibitor (R115777) for the first two months of treatment. The second phase of treatment is given after window therapy is completed or at the start of treatment for patients who choose not to participate in window therapy. During this phase of treatment, the drug 13-Cis Retinoic Acid (C-RA is given with the drugs Cytosine Arabinsodie (Ara-C) and Fludarabine (Flu). Patients will then receive radiation therapy followed by bone marrow transplant.
ELIGIBILITY
  1. All children with newly diagnosed, previously untreated JMML will be eligible for this treatment protocol.
  2. Patients must have adequate liver and kidney function.
CONTACT Kay Krimmel 216-844-3999
TITLE ABTR01B1: A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
DESCRIPTION This study will accomplish the collection of pediatric cancer-related or benign tumor-related biological specimens including specimens from patients with rare pediatric tumors from Children’s Oncology Group (COG) institutions for cases in which there is no disease specific protocol. 
ELIGIBILITY
  1. Biological specimens, defined as malignant or benign tumor-related cells/tissue including solid tumors and leukemia, must be available for submission.
  2. Pathology review specimens must be available for submission for central review and include nasopharyngeal carcinoma, thyroid carcinoma, melanoma and dysplastic nevi (atypical moles), adrenocortical carcinoma, colorectal carcinoma, pleuropulmonary blastoma, embryonal undifferentiated sarcoma of the liver, other rare tumors as defined by a participating COG institution.
  3. Patients must not be eligible for a disease-specific biology/banking protocol. 
  4. Patients are eligible t the time of diagnosis of their primary neoplasm (benign tumor-related or malignant), or at the time of second look surgery, or at the development of a second malignant neoplasm.
CONTACT Kay Krimmel 216-844-3999
TITLE AAML0123: A Phase II Study of Gleevec in Philadelphia Chromosome Positive (Ph+) Chronic Phase Chronic Myelogenous Leukemia
DESCRIPTION This study will estimate the response rate of Gleevec administered orally daily without interruption to children with Ph+ CML. Gleevec will be administered by mouth, once daily. Each 28-day period will be considered a treatment course. Patients who are responding to therapy may continue on therapy in the absence of significant toxicities.
ELIGIBILITY
  1. Patients must have a Ph+ chronic phase CML and most have either recurred after stem cell transplant or subsequent chronic phase; newly diagnosed CML in first chronic phase with no prior chemotherapy other than hydroxyurea.
  2. Patients must have a life expectancy of greater than or equal to 8 weeks.
  3. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  4. At least 3 months must have elapsed since stem cell transplant or craniospinal XRT.
  5. At least 2 weeks must have elapsed since local palliative XRT and at least 6 weeks must have elapsed if other substantial BM radiation.
  6. Patients must have adequate kidney, liver and CNS function.
CONTACT Kay Krimmel 216-844-3999
TITLE AALL03B1: Classification of Acute Lymphoblastic Leukemia
DESCRIPTION This study will provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed ALL to a specific therapeutic trial. 
ELIGIBILITY
  1. Patients must have newly diagnosed acute leukemia with at least 25 percent blasts in the bone marrow or peripheral blood with 50 percent blasts if bone marrow aspiration is not performed.
  2. Patient may have suspended acute Lymphoblastic leukemia.
CONTACT Kay Krimmel 216-844-3999
TITLE AALL0232: High Risk B-Precursor Acute Lymphoblastic Leukemia, A Phase III Group-Wide Study
DESCRIPTION This study is being done to improve the outcome of children with high-risk acute Lymphoblastic leukemia. Patients will be randomized to 14 days of dexamethasone versus 28 days of prednisone during Induction and Capizzi escalating Methotrexate versus high dose Methotrexate during Interim Maintenance. Patients may receive Day 1 intrathecal cytarabine prior to randomization.
ELIGIBILITY
  1. Patients must be eligible for an enrolled on AALL03B1.
  2. Patients must have newly diagnosed B-precursor ALL.
  3. Patients must have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine.
  4. Patients must be enrolled on the study before systemic treatment begins. The only exceptions to this include previous treatment with corticosteroids.
CONTACT Kay Krimmel 216-844-3999
TITLE AEWS0331: European Ewing Tumor Working Initiative of National Groups Ewing Tumor Studies 1999 (EURO-E.W.I.N.G. 99)
DESCRIPTION This study will compare VAI (Vincristine, Adriamycin, and Ifosphamide) consolidation chemotherapy with VAC (Vincristine, Ifosfamide, Dactinomycin, and Etoposide) consolidation chemotherapy in patients with non-metastatic Ewing tumor and good histological to standard induction VIDE chemotherapy or in patients with localized Ewing tumor who receive radiotherapy as primary local treatment following standard induction VIDE chemotherapy. All patients will start therapy with 4 courses of chemotherapy with VIDE. After courses 3 and/or 4 a stem cell collection will be done. Patients will then have two more courses of VIDE. Some patients may have surgery and some patients may have radiation therapy. Patients will then be randomized to receive either seven more courses of VAI and whole lung radiation or Busulfan-Melphalan, stem cell transplant, and possibly whole lung radiation therapy.
ELIGIBILITY
  1. Patients must have histologically confirmed Ewing Tumor (Ewing’s sarcoma or peripheral PNET) or bone or soft tissue.
  2. Patients must not have received prior chemotherapy.
  3. Patients must be registered at diagnosis.
  4. Patients must have normal cardiac, and liver function.
CONTACT Kay Krimmel 216-844-3999
TITLE D9902: A COG Soft Tissue Sarcoma Biology and Banking Protocol
DESCRIPTION This study will facilitate the collection of human tissue and other biologic specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcomas and non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) diagnosed and/or treated at COG member institutions. 
ELIGIBILITY
  1. Patients must have an institutional diagnosis of rhabdomyosarcoma (RMS) or non-rhabdomyosarcoma soft tissue sarcoma (NRSTS, including aggressive fibromatosis, Desmoplastic round cell tumors, and malignant rhabdoid tumors) or other soft tissue neoplasms established by pathologic examination of tissue or bone marrow and must have pathologic specimens of tumor-containing tissue or bone marrow beyond that needed by the institution for rendering the diagnosis.
  2. Patients with Ewing sarcoma/PNET or osteogenic sarcoma are not eligible for this protocol.
CONTACT Kay Krimmel 216-844-3999
TITLE ANBL00B1: Neuroblastoma Biology Studies
DESCRIPTION This study will prospectively analyze the factors that are currently used for risk-group assignment in Neuroblastoma tumors at the time of diagnosis. This study is designed to allow for acquisition of centralized, high-quality data from tumor specimens (MYCN and ploidy and histopathology) that are essential for patient management.
ELIGIBILITY
  1. Patients must have newly diagnosed Neuroblastoma seen at COG institutions.
  2. Patients must be registered within 2 weeks following diagnosis and every effort should be made to register patients within 1 week of diagnosis.
  3. Patients with relapsed Neuroblastoma who were not enrolled on ANBL00B1 at diagnosis are not eligible.
CONTACT Kay Krimmel 216-844-3999
TITLE AEWS02B1: A Groupwide Biology and Banking Study for Ewing Sarcoma
DESCRIPTION The purpose of this study is to develop a mechanism to collect and distribute tumor specimens to various investigators, and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken. 
ELIGIBILITY
  1. All patients with either newly diagnosed or recurrent Ewing Sarcoma are eligible.
  2. Patients are not required to enter a therapeutic study to register to this study.
  3. Patients should be registered within two weeks of diagnosis.
CONTACT Kay Krimmel 216-844-3999
TITLE CCG A 5971: Randomized, Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma
DESCRIPTION This study will compare the event free survival and survival in patients with disseminated lymphoblastic lymphoma. Patients with disseminated lymphoblastic lymphoma will be randomly assigned to receive one of four chemotherapy regimens.
ELIGIBILITY
  1. Newly diagnosed lymphoblastic lymphoma.
  2. Less than 25% tumor cells in the bone marrow.
  3. Patients must be at least 12 months old and less than 22 years old at study entry.
  4. Adequate heart function. 
  5. Patients must not have received prior chemotherapy. Intrathecal cytarabine is allowed if administered within 72 hours of starting protocol therapy.
CONTACT Kay Krimmel 216-844-3999
TITLE CCG P 9645: Intergroup Protocol for Treatment of Children with Hepatoblastoma
DESCRIPTION This study will compare the event-free survival rate of patients with Stage II/IV unresectable or metastatic hepatoblastoma. Patients are divided into groups based on their type of tumor. Patients in group 1 will be treated with surgery alone. Patients in group 2 will be randomized to receive either cisplatin + vincristine + 5FU or amifostine + cisplatin + vincristine + 5FU. Patients in group 3 will be randomized to receive either carboplatin + cisplatin or amifostine + carboplatin + cisplatin.
ELIGIBILITY
  1. Patients must have biopsy proven
  2. hepatoblastoma and must be registered not more than 28 days from initial surgical procedure.
  3. Patients must not have received prior therapy (except tumor resection).
  4. Patients with hepatocellular carcinoma are not eligible.
    Patients must have normal renal function.
CONTACT Kay Krimmel 216-844-3999
 
TITLE CCG 2961: A Phase II Study of Children with Untreated Acute Myelogenous Leukemia
DESCRIPTION The objective of this study is to exceed a 50% five year event-free survival in patients with untreated acute myelogenous leukemia or myelodysplastic syndrome. Induction consists of idarubicin, etoposide, dexamethasone, Ara-C, and 6-thioguanine given on days 0-3 followed by daunorubicin, etoposide, dexamethasone, Ara-C and 6-thioguanine given on days 10-13. Patients are then randomly assigned to consolidation consisting of the same sequence of 5 and 5 drugs or to fludarabine/Ara-C/idarubicin.
ELIGIBILITY

 

  1. Children > 1 month and < 21 years 
  2. Previously untreated morphologically diagnosed myeloid leukemia except FAB M3. Patients with granulocytic sarcoma, documented preleukemia (myelodysplastic syndrome), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, refractory anemia, refractory anemia with ringed sideroblasts, and mixed lineage leukemia are eligible. 
  3. No prior chemotherapy or radiation therapy.
CONTACT Kay Krimmel 216-844-3999
 
TITLE ACNS02B3: A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
DESCRIPTION This study will accomplish the collection of brain tumor tissue and an accompanying blood sample as biological specimens from patients treated at Children’s Oncology Group (COG) institutions. The Children’s Oncology Group Bank at the COG Biopathology Center along with other approved COG sites will serve as repositories for banking brain tumor and other biological specimens from pediatric patients.
ELIGIBILITY
  • Patients treated for brain tumor at a COG institution.
  • Brain tumor biological specimens, derived from primary tumors of the central nervous system, must be available for submission.
CONTACT Kay Krimmel 216-844-3999
 
TITLE CCG D9803: Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide versus Vincristine, Actinomycin-D and Cyclophosphamide Alternating with Vincristine, Topotecan and Cyclophosphamide for Patients with Intermediate Risk Rhabdomyosarcoma
DESCRIPTION This study will compare the early response rates and survival of patients with intermediate risk rhabdomyosarcoma treated with surgery + radiation therapy and vincristine, actinomycin-D and cyclophosphamide or the same alternating with a new combination which substitutes topotecan for actinomycin-D. 
ELIGIBILITY

 

  1. Age < 21 years.
  2. Non-metastatic alveolar rhabdomyosarcoma, undifferentiated sarcoma or ectomesenchymoma.
  3. Stages 2 and 3, Clinical Group III embryonal rhabdomyosarcoma and ectomesenchymoma with embryonal features.
  4. Patients < 10 years of age with Stage 4, Clinical Group IV embryonal rhabdomyosarcoma and ectomesenchymomas with embryonal features.
  5. No prior chemotherapy.
  6. Adequate renal and liver function.
CONTACT Kay Krimmel 216-844-3999
 
TITLE CCG 9952: Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than 10 Years Old
DESCRIPTION This study will compare the event-free survival as a result of treatment with either carboplatin and vincristine or a combination of thioguanine, procarbazine, CCNU and vincristine.
ELIGIBILITY

 

  1. Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision with necessity to begin treatment because of a risk of neurologic impairment with progression. All patients on study must have residual tumor.
  2. Astrocytoma or other eligible tumors (oligodendroglial, mixed gliomas, neuronal, chiasmatic-hypothalamic tumor without histologic confirmation) interpreted as low grade (WHO grades I and II).
  3. Age less than 10 years.
  4. Intrinsic brainstem tumors of the pons or intrinsic to the optic nerve within the orbit without intracranial extension and involvement of the optic chiasm are not eligible.
  5. Children with clinically or radiographically progressive tumors must be enrolled and randomized within six weeks of clear radiological or clinical evidence or progression. Children with newly diagnosed incompletely resected tumors who are considered to require immediate therapy must be enrolled within six weeks of surgery.
  6. No prior therapy except diuretics, corticosteroids and surgery.
  7. Adequate renal function.
CONTACT Kay Krimmel 216-844-3999
 
TITLE CCG 99701: A Groupwide Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients with Newly Diagnosed High Risk Central Nervous System Embryonal Tumors
DESCRIPTION This study will determine a feasible dose and duration of carboplatin given daily with craniospinal and local boost radiotherapy along with weekly vincristine to children with high-risk PNET.
ELIGIBILITY
  1. Must have histologic verification of PNET at diagnosis. Patients with one of the following diagnoses will be eligible: primitive neuroectodermal tumor, atypical teratoid/rhabdoid tumor, medulloblastoma, desmoplastic medulloblastoma, ependymoblastoma, medullomyoblastoma, spongioblastoma, spongioblastoma polare, spongioblastoma - primitive polar, medulloepithelioma, neuroblastoma NOS, pineoblastoma.

  2. Age > 3 years and less than 22 years at time of diagnosis

  3. No prior chemotherapy or radiotherapy

  4. Adequate bone marrow, kidney, and liver function

  5. Must begin treatment within 31 days of definitive surgery

CONTACT

Kay Krimmel 216-844-3999

 
TITLE AHOD0031: A Phase III Group-Wide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin’s Disease
DESCRIPTION This trial will compare response-based therapy to standard therapy for intermediate risk Hodgkin’s disease.  At the time of study entry patients must agree to the possible randomizations based on response to treatment.  All patients will receive 3 cycles of ABVE-PC.  Thos with a rapid early response will receive an additional 1 cycle of ABVE-PC.  Rapid early responders, who have sustained a CR following a total of 4 cycles of ABVE-PC chemotherapy will be randomized to either a reduced therapy arm or consolidative low dose involved field radiation therapy (IFRT).  Those with less than a complete response will receive IFRT.  Patients with a slow early response to 3 cycles of ABVE-PC will be randomized to receive 1 additional cycle of ABVE-PC versus 1 additional cycle of ABVE-PC preceded by 2 cycles of DECA.  All patients who are slow early responders will receive consolidative low dose IFRT.
ELIGIBILITY
  1. Patients with newly diagnosed, pathologically confirmed Hodgkin’s disease are eligible.

  2. Patients ages 0 – 21 years are eligible.

  3. Patients must have adequate renal, hepatic, cardiac and pulmonary function.

  4. Patients may not have received any previous chemotherapy or radiation therapy.

CONTACT

Kay Krimmel 216-844-3999

 
TITLE AALL0031: A Children’s Oncology Group Pilot Study for the Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents (STI571 [Gleevec]) – A Phase III Group-Wide Study
DESCRIPTION This study will determine the feasibility in terms of patient and toxicity of an intensified chemotherapeutic regimen incorporating novel agents for treatment of children and adolescents with very high risk (VHR) ALL.  Patients will receive frontline induction/consolidation chemotherapy for 4 to 15 weeks.  Patients will then receive consolidation chemotherapy consisting of ifosfamide, etoposide, methotrexate and STI-571 (for PH+ ALL only) and radiation (if indicated) for 3 weeks.  Patients will then receive consolidation block 2 consisting of high dose Methotrexate, intrathecal Methotrexate and high dose cytarabine.  Patients meeting transplant criteria will then receive a transplant chemotherapy regimen consisting of TBI, etoposide and cyclophosphamide followed by hematopoietic stem cell transplantation.  Patients not eligible for transplant will receiving reinduction block 1 which consists of daunorubicin, cyclophosphamide, vincristine, L-asparaginase, dexamethasone, Methotrexate and STI 571 (Ph+ ALL only) for 3 weeks followed by intensification block 1 which consists of IV Methotrexate, intrathecal Methotrexate, etoposide, cyclophosphamide, high dose cytarabine, L-asparaginase and STI 571 (Ph+ ALL only).  These chemotherapy regimens will be repeated if patients have residual disease.
ELIGIBILITY
  1. Patients must have a diagnosis of ALL and must fall into one of the following 4 subgroups: 1) Ph+ ALL; 2) hypodiploid patients with greater than or equal to 44 chromosomes; 3) patients who had an M3 (less than 25% blasts)