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 Leukemia Trials
TITLE SCIO 1Z05: A Randomized, Multicenter, Open-Label, Modified Dose-Ascension, Parallel Study of the Safety, Tolerability, and Efficacy of Oral SCIO-469 in Patients with Myelodysplastic Syndromes (MDS)
DESCRIPTION The purpose of this study is to evaluate the safety and tolerability of SCIO-469 in patients with myelodysplastic syndromes. 
Patients will be assigned to one of four treatment groups with varying dose levels of SCIO-469.
ELIGIBILITY
  1. Age ≥ 18 years
  2. Diagnosis of MDS (including non-proliferative CMML) of at least 8 weeks duration. MDS must not be treatment-related
  3. Must not have myelosclerosis (or myelofibrosis) occupying > 30% of marrow space
  4. Must have failed prior erythropoietin treatment
  5. ECOG performance status 0 – 2
  6. Patients must have normal liver and kidney function.
CONTACT Donna Kane, RN 216-844-8123
TITLE CASE 4Y04: A Phase II Trial of Combination Therapy with Thalidomide, Arsenic Trioxide, Dexamethasone, and Ascorbic Acid (TADA) in Patients with Chronic Idiopathic Myelofibrosis or Overlap Myelodysplastic/Myeloproliferative Disorders
DESCRIPTION This study will determine whether a combination of Trisenox, Thalidomide, dexamethasone, and ascorbic acid (vitamin C) is safe and effective for the treatment of myelofibrosis or overlap myelodysplastic/myeloproliferative disorder syndrome. The study will also determine if the combination of drugs will increase blood counts; reduce the number of red blood cells that must be transfused; and improve fatigue. In the first week, Trisenox (a drug given intravenously) and ascorbic acid (a pill) will be given on 5 days in a row. In weeks 2 through 11, they will be given twice a week. Thalidomide is given daily, by mouth, throughout the study.
ELIGIBILITY
  1. Patients must have one of the following diagnoses: chronic idiopathic myelofibrosis (with extramedullary hematopoiesis), chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease [MPD] unclassifiable, or myelodysplastic syndrome with > 2+ fibrosis present in the bone marrow. Subjects with MPD must be negative by FISH for the BCR/ABL fusion gene
  2. No prior therapy with arsenic trioxide or thalidomide
  3. Must have adequate platelets; serum potassium and serum magnesium; and bone marrow, kidney, liver and heart organ function
  4. Must have an ECOG performance status 0-2
  5. Must be at least 18 years of age
  6. Must have life expectancy greater than 3 months
CONTACT Donna Kane, RN 216-844-8123
TITLE E 2903 Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia
DESCRIPTION This study is being done to determine if patients with chronic lymphocytic leukemia, who have been previously treated for this disease, can achieve a remission and whether their length of remission will be increased with CAMPATH-1H treatment. The study drugs (pentostatin, cyclophosphamide, and rituximab) will be given every 3 weeks (21 days) for up to 6 months. Patients who respond to this treatment by achieving a complete remission will receive CAMPATH-1H by subcutaneous injection 3 times per week for 4 weeks. If disease is still present after the first cycle of treatment or if it has progressed during the first course of treatment, patients will receive CAMPATH-1H three times per week for 18 weeks. 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of chronic lymphocytic leukemia as defined by study criteria.
  2. Patients must require chemotherapy, and the last chemotherapy must have been competed at least 6 weeks prior to the study treatment.
  3. Patients must have disease progression or failed to achieve a meaningful response to chemotherapy, or relapsed after chemotherapy, according to study criteria.
  4. Patients may have received prior rituximab therapy according to study criteria.
  5. Patients must be over 18 years of age.
  6. Patients must have ECOG performance status of 0-2.
  7. Patients must have adequate kidney and liver function.
CONTACT Donna Kane, RN 216-844-8123
TITLE E 2902 A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure
DESCRIPTION This study is being done to see how well the experimental drug, Farnesyl Transferase Inhibitor (FTI) R115777, can affect disease-free survival in patients with acute myeloid leukemia in second or subsequent complete remission or following primary induction failure. Patients will be randomized into 2 groups. Group A will receive the study drug, R115777, in pill form to be taken orally twice a day for 21 days for 21 days followed by 7 days without taking the pill as long as the leukemia is in remission. Patients in Group B will receive no further treatment, but health status will be monitored.
ELIGIBILITY
  1. Patients must have a diagnosis of acute myeloid leukemia and be in complete remission following primary induction failure or be in second or subsequent complete remission according to study criteria.
  2. Patients who have received consolidation chemotherapy, autologous stem cell transplant, or any form of post-remission therapy are eligible for this study.
  3. Patients with a history of extramedullary disease may be eligible according to study criteria.
  4. Patients who have received an allogeneic transplant in their current remission are not eligible for this study
  5. Patients with acute promyelocytic leukemia are not eligible for this study.
  6. Patients must not have active cardiac, pulmonary, kidney or liver disease.
CONTACT Donna Kane, RN 216-844-8123
TITLE CASE 3904: Phase I and Pharmacodynamic Study of SB-715992 in Acute Leukemias
DESCRIPTION This study will determine the maximum tolerated dose (MTD) of SB-715992. Patients will receive escalated doses of IV SB-715992. Induction treatment will be given for 3 consecutive days every 21 days for a maximum of 3 consecutive cycles. Patients who achieve a complete or partial response or stable disease will be eligible to receive additional consolidation courses of treatment every 3 week for a maximum of 4 cycles.
ELIGIBILITY
  1. Patients must have AML or ALL refractory to primary standard induction therapy; CML in blast crisis; advanced myelodysplastic syndrome RAEB or RAEB-2 (providing they are neutropenic or transfusion dependent).
  2. At least 2 weeks must have elapsed between completion of most recent cytotoxic chemotherapy, or biologic therapy except for hydroxyurea or corticosteroids or Imatinib.
  3. Patients who have previously received an autologous stem cell transplant are allowed providing a minimum of 3 months has elapsed from transplant and patient has recovered from all transplant-associated toxicities.
  4. Patients must have a life expectancy of at least 4 weeks.
  5. Patients must have normal liver and kidney function
CONTACT Nancy Horvath, RN 216-844-7087
TITLE E3903: Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders
DESCRIPTION This study is being done to provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients for accrual to ECOG leukemia trials. Samples of required diagnostic materials are to be submitted to ECOG. These samples will undergo a diagnostic review and patients may register to ECOG treatment trial.
ELIGIBILITY
  1. Patients must be considered for enrollment into one or more ECOG treatment trials for acute or chronic leukemia.
  2. Any ECOG treatment protocol that is being considered for the patient must be active and accruing.
  3. Patients must not yet have started treatment on their respective ECOG treatment trial.
  4. Patients may be entered simultaneously on this laboratory protocol and a chosen treatment protocol if immediate treatment is medically indicated.
CONTACT Nancy Horvath, RN 216-844-7087
TITLE NOVA 1903: A Non-Randomized Open Label Study of Molecular Response to High Dose Gleevec (imatinib Mesylate, formerly known as STI571) in Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
DESCRIPTION This study will determine the rate of molecular response in newly diagnosed adult patients with Ph+/or Ph-/Bcr-Abl positive early chronic phase CML. Patients will receive Gleevec once a day by mouth for up to 18 months. Treatment after completion of the 18 month study is at the discretion of the investigator.
ELIGIBILITY
  1. Patients must have a diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome or variants of (9,22) translocations, or patients with Philadelphia chromosome negative but Bcr-Abl gene positive.
  2. Patients must be within 6 months of diagnosis.
  3. Patients in late chronic phase, accelerated phase or blastic phase are excluded.
  4. Patients with identified sibling donors where allogeneic bone marrow transplantation is elected as the first line treatment are not eligible.
  5. Patients must have normal bone marrow, liver and kidney function.
CONTACT Nancy Horvath, RN 216-844-7087
TITLE MSKCC 1Y02: A Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders
DESCRIPTION This study will determine the frequency and duration of complete and partial response rates for patients with low grade lymphoproliferative disorders treated with PS-341 when administered twice weekly followed by a one week rest period. Patients will receive intravenous PS-341 twice weekly for two weeks every three weeks with a one week rest period (i.e., one cycle equals three weeks). Treatment may continue for as long as there is clinical benefit or until disease progression or unacceptable toxicities.
ELIGIBILITY
  1. Patients must have histologically or histologically confirmed using the REAL Classification, relapsed /or refractory: chronic lymphocytic leukemia; B-cell small lymphocytic lymphoma; any marginal zone lymphoma; follicle center cell lymphoma, grade I, II, III; mantle cell lymphoma; Waldenstrom’s macroglobulinemia.
  2. For NHL, all patients must have measurable disease.
  3. Patients should have received no more than three prior regimens of conventional cytotoxic chemotherapy for at least four weeks prior to study enrollment (6 weeks for BCNU or mitomycin C). At least 7 days must have elapsed since steroids. A period of at least 3 months must have elapsed since the last administration of any monoclonal antibody.
  4. Patients must be at least 18 years of age.
  5. Patients must have adequate bone marrow, cardiac, kidney, and liver function.
CONTACT Nancy Horvath, RN 216-844-7087
TITLE CWRU 1902: Phase II Study of Fludarabine, Carboplatin, and Topotecan with Thalidomide for Patients with Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes
DESCRIPTION The purpose of this study is to evaluate the effectiveness, side effects and recovery time of a combination of chemotherapy drugs. Approximately 40 patients will be enrolled on this treatment program. In clinical studies, carboplatin and topotecan, each used as a single agent, have been shown to induce remission in some patients with acute leukemia and advanced myelodysplastic syndrome.
ELIGIBILITY
  1. AML in first or second relapse or refractory, CML blast crises at diagnosis or after a trial of STI-571, myelodysplastic syndrome, AML secondary to chemotherapy, acute promyelocytic leukemia who have failed a trial of ATRA and arsenic, relapse from autologous stem cell transplant more than 3 months prior.
  2. 18 years of age or older
  3. ECOG performance status of 0, 1, or 2
  4. Adequate hepatic and renal function
  5. No poorly controlled pulmonary, cardiac, or infectious disease
  6. Not HIV seropositive
  7. No active central nervous system leukemia or sever peripheral neuropathy
CONTACT Clinical Trials Core Facility
216-844-5829
216-844-5857
TITLE ECOG 4999: Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients with Relapsed or Refractory Acute Myelogenous Leukemia
DESCRIPTION The main purpose of the clinical study is to find out which of several new combinations of drugs are most effective in putting leukemia into remission. Approximately 165 people will take part in this study nationwide. There are three arms for randomization to different groups of drugs.
ELIGIBILITY
  1. Morphologic proof of a type of acute myelocytic leukemia
  2. Relapse in less than 6 months, relapse in 6-12 months, or refractory to conventional initial induction chemotherapy
  3. No history of significant cardiac disease with normal cardiac ejection fraction
  4. No prior treatment with gemtuzumab ozogamicin, liposomal daunorubicin, or topotecan
  5. ECOG performance status of 0-2
  6. No chemotherapy or radiotherapy within 4 weeks prior to study entry
  7. Not pregnant or breast feeding
  8. No current evidence of invasive fungal infection
CONTACT Thelma Vawters 216-844-8146
TITLE E 2993: Phase III Randomized Trial of Autologous and Allogeneic Bone Marrow Transplantation versus Intensive Conventional Chemotherapy I Acute Lympoblastic Leukemia in First Remission
DESCRIPTION This compares post-remission therapies of allogeneic versus autologous bone marrow transplant versus intensive conventional chemotherapy. Combinations of drugs will be used for the initial two part therapy prior to randomization.
ELIGIBILITY
  1. Pathologic proof of ALL
  2. Previously untreated for malignancy
  3. Between 15 and 60 years of age
  4. No organ damage or medical problems that would jeopardize outcome of therapy
  5. No significant cardiac disease
  6. Not known to be HIV antibody positive
CONTACT Thelma Vawters 216-844-8146
TITLE ICC 3402: A Phase I Trial of PS-341 and Fludarabine for Relapsed and Refractory Indolent Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
DESCRIPTION This study will determine the toxicity and safety of PS-341 and Fludarabine in relapsed and refractory indolent non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.  Patients will receive PS-341, IV on days 1, 4, 8 and 11 followed by a 10 day rest.  Fludarabine will be given one hour after PS-341, IV over 30 minutes on days 2 through 3 of each cycle (1 cycle = 3 weeks).  Patients may receive up to a maximum of 8 cycles.
ELIGIBILITY

  1. Patients must have relapsed or refractory (progressive) indolent non-Hodgkin’s lymphoma.

  2. Patients with non-Hodgkin’s lymphoma must have measurable disease.

  3. Patients with relapsed indolent NHL (including CLL) will be enrolled in first, second, third relapse, or indolent NHL patients with progressive disease.

  4. Prior fludarabine therapy is allowed; however patients should not have been previously treated with PS-341.

  5. Patients who are candidates for potentially curative transplant therapies should not be entered on this study.

  6. Patients must have normal bone marrow, hepatic and renal function.

CONTACT Nancy Horvath, RN 216-844-7087

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