Clinical Trials

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Phase I Trials
TITLE CASE 5Y05: A Phase I Study of Bevacizumab in Combination with SU11248
DESCRIPTION This study will determine the maximum tolerated dose of bevacizumab + SU11248. Patients will receive an infusion of bevacizumab 
through the vein once every 2 weeks and will take SU11248 tablets once a day by mouth for 4 weeks, then take no pills for the next 2 weeks. 
This 6-week cycle is then repeated.
ELIGIBILITY
  1. Patient must have histologically proven solid tumor malignancy not amenable to curative surgical or radiation therapy.
  2. Must not have had prior treatment with bevacizumab, SU11248 or other therapy directed against VEGF
  3. Patients must have received ≤ 2 prior systemic treatment regimens.
  4. Age ≥ 18 years
  5. ECOG performance status 0 or 1.
  6. Patients must have normal bone marrow, liver and kidney function.
CONTACT Angela Zambito, RN 216-844-5546 
TITLE CASE 2Y04: Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients with Advanced Solid Tumors.
DESCRIPTION This study will determine the maximum amount of Revlimid that can be tolerated by patients with advanced solid tumors. It will also determine how well the patient’s tumor(s) responds and whether prolonged freedom from disease is achieved. Patients will be given Revlimid by mouth on days 1 through 14, and they will also be given docetaxel intravenously (by injection into a vein) every 21 days.
ELIGIBILITY
  1. Must have any solid tumor type (e.g., head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, sarcoma, gynecological, or others) that cannot be treated satisfactorily by conventional treatment
  2. Must have an ECOG performance status of 0-2
  3. Must have adequate bone marrow, liver and kidney function
  4. Can have prior chemotherapy and limited radiation
  5. Must be 18 years of age or older
  6. Must have life expectancy of at least 4 months
CONTACT Angela Zambito, RN 216-844-5546 
TITLE GLAX 1Y04:  An Open Label, Phase Ib Roll-Over Study to Assess the Long-Term Safety Profile of Lapatinib in Cancer Patients
DESCRIPTION This is a study to determine the long-term safety and tolerability of lapatinib as monotherapy or as part of a combination regimen of therapy for advanced or metastatic breast cancer. Patients may continue in this study until disease progression, unacceptable toxicity, maximum benefit, or until commercial supplies of lapatinib are available locally.
ELIGIBILITY

Patients must be experiencing therapeutic benefits while receiving treatment with lapatinib through participation in a Phase I study of lapatinib.Patients may be male or female.

CONTACT Leda Dumadag, RN  216-844-5829
TITLE CASE 2204  A Phase IB Study in Patients with Metastatic Colorectal Cancer to Evaluate Pharmacodynamic Effects of Erlotinib and Safety and Efficacy of Erlotinib in Combination with modified FOLFOX6 (mFOLFOX6) and Beracizumab.
DESCRIPTION This is study is being done to characterize the inhibition of pEGFR (epidermal growth factor receptor) after treatment with oral Erlotinib daily in patients with metastatic colorectal cancer.  Modified FOLFOX 6 chemotherapy (oxaliplatin, 5-fluororuacil, and leucovorin) begins in cycle 2 or 3 depending on the dose of Erlotinib tolerated by patient. Patients will continue in the study until disease progression, intolerance of side effects, or withdrawal of consent.
ELIGIBILITY
  1. Patients must have histologically proven metastatic colorectal cancer.
  2. Patients must have recovered from the side effects of cytotoxic chemotherapy, radiation treatment and/or major surgery that could interfere with protocol therapy.
  3. Patients must have a life expectancy of at least 3 months.
CONTACT Anne Ness RN 216 844-1637
TITLE CASE 9804  Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients with Locally Advanced Cervical and Pelvic Malignancies
DESCRIPTION This is a study being done to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of capecitabine when given in combination with pelvic external beam radiotherapy and intracavitary brachytherapy for the treatment of cervical cancer.  Patients will receive external radiation for 5 weeks.  During or following radiation therapy patients may receive radiation from a radioactive source placed into the uterus and vagina for a period of time.  Intracavitary placement will be performed once a week for 1 or 2 weeks.  During this treatment patients will receive oral capecitabine twice daily.  Radiations treatment and capecitabine will be completed in about 7 weeks.  Patients will remain in the study until completion, disease progression or experience severe side effects.
ELIGIBILITY
  1. Patients must have pathologically-proven primary or recurrent advanced cervical cancer or other pelvic malignancy not amendable to curative surgical resection alone.
  2. Patients must have bi-dimensional measurable or clinically estimable disease.
  3. Prior chemotherapy and/or radiation is allowable for non-gynecologic cancers as long as appropriate exclusion criteria have been met.
  4. Patients have refused or are not candidates for cisplatin chemotherapy as a consequence of renal insufficiency, prior platinum adverse sensitivity, pre-existent neuropathy or intercurrent co-morbid disease are eligible for the study.
  5. Patients must have normal liver, kidney and bone marrow function.
CONTACT Elisa Eldermire RN 216 844-8787
TITLE CASE 1Y04: Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions
DESCRIPTION This study will determine the maximum tolerated dose of topically delivered Pc 4-PDT in the therapy of pre-malignant and malignant skin conditions. Pc 4, at increasing dose levels, is applied over the skin lesion. Visible light, at increasing dose levels is then delivered over the Pc 4 treated area.
ELIGIBILITY
  1. Patients must have biopsy proven diagnosis of actinic keratoses, Bowen’s disease, squamous cell carcinoma, basal cell carcinoma or mycosis fungoides (stage IA, IIA, IB or IIB for mycosis fungoides)
  2. Fitzpatrick skin type I-IV
  3. No anticancer therapy within two weeks prior to Pc -PDT
  4. Performance status 0-2
  5. Patients must have been off photosensitizing medications for the previous two weeks prior to enrollment
  6. Patients must not have a significant history of photosensitivity, including a diagnosis of porphyria, lupus erythematosus, xeroderma pigmentosum, severe polymorphous light eruption and solar urticaria
  7. Must not have existing diabetes mellitus
  8. Must not have know hypersensitivity to ethanol/propylene glycol
CONTACT Heather Scull MS, 216-844-7834 
TITLE S0355: A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction
DESCRIPTION This study will define levels of hepatic impairment at which dose modifications of BMS-247550 are required. Patients will be stratified to one of four groups based on liver function. Patients will receive BMS-247550 on day 1 of a 21-day cycle.
ELIGIBILITY
  1. Patients must have histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective.
  2. Patients with a liver mass, raised alpha-fetoprotein level and positive serology for hepatitis, consistent with a diagnosis or hepatocellular carcinoma will be eligible without the need for pathological confirmation or the diagnosis.
  3. Patients with gliomas or brain metastases who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for one month prior to enrollment.
  4. Patients with active hemolysis are not eligible.
  5. Patients must have normal bone marrow and kidney function.
CONTACT Anne Ness RN 216-844-1637
TITLE E 2A01: A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan with Stem Cell Reconstitution for Patients with Primary Systemic Amyloidosis
DESCRIPTION This study will find the maximum tolerated dose of Melphalan with amifostine in primary amyloidosis patients. During the stem cell collection period, patients will receive G-CSF for approximately 5 days followed by stem cell collection. Within six weeks of the last stem cell collection, patients will receive IV amifostine on two days as a five-minute infusion. Melphalan with be given a single IV infusion for 5 minutes at varying dose levels followed by autologous peripheral stem cell infusion 24 hours after the infusion of Melphalan.
ELIGIBILITY
  1. Patients must have a histologic diagnosis of amyloidosis with a presence of a monoclonal protein determined by either immunoelectrophoresis or immunofixation of the serum or urine.
  2. Patients must not have primary amyloidosis manifested only by carpal tunnel syndrome or purpura. Amyloid deposits in a plasmacytoma or in the vessels of a bone marrow in an otherwise asymptomatic individual do not constitute an amyloid syndrome.
  3. Patients must not have multiple myeloma defined by the presence of lytic bone disease or greater than 30% bone marrow plasma cells. Patients must not have secondary familial or localized amyloid.
  4. Patients must be between 18 and 70 years of age.
  5. Patients must have adequate bone marrow, liver and kidney function.
CONTACT Thelma Vawters 216-844-8146
TITLE GLAX 1Y02: A Phase I, Open Label, Multiple Dose, Dose Escalation Study of GW786034 in Patients with Solid Tumors
DESCRIPTION This study will assess the safety and tolerability of oral GW786034 following twice daily dosing in cancer patients. Patients will receive a single dose of GW786034 on day 1. Twice daily dosing will begin on day 2. 
ELIGIBILITY
  1. Patients must have histologically confirmed diagnosis of advanced solid tumor refractory to standard therapy or for whom there is no standard therapy.
  2.  Patients must be at least 21 years of age.
  3. Patients must be able to swallow and retain oral medication.
  4. Patients must have adequate bone marrow, hepatic and renal function.
  5. Patients must not have had any major surgery, hormonal or steroid therapy (other than replacement), chemotherapy, radiotherapy, immunotherapy or other investigational agent within the last 4 weeks (6 weeks for prior nitrosourea or mitomycin C).
CONTACT Anne Ness, RN 216-844-1637
 
TITLE UWCC 1Y03: A Phase I Pharmacokinetic Study of PS-341 in Patients with Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
DESCRIPTION This study will determine the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with advanced malignancy and mild, moderate or severe renal insufficiency.  Patients will be stratified to one of 5 different treatment groups with different starting doses of PS-341 based on renal function.  Patients will receive PS-341 IV over 3-5 seconds on days 1, 4, 8 and 11 of a 21 day cycle. 
ELIGIBILITY
  1. Patients must have histologic proof of malignancy.

  2. Patients must have adequate bone marrow and liver function.  Patients with abnormal kidney function will be allowed and will be grouped accordingly.

  3. Patients must be greater than or equal to 18 years of age.

  4. Patients must be willing to provide all biologic specimens as required by the protocol.

  5. Patients must not have a known standard therapy for patient’s disease that is potentially curative or definitely capable of extending life expectancy.

  6. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy or concurrent use of other investigational agents (bisphosphonate therapy will not be considered investigational agents for the purpose of trial eligibility).

CONTACT Anne Ness RN 216-844-1637
 
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
 
TITLE CWRU 1301: A Phase I Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, OSI-774, in Combination with Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
DESCRIPTION The purpose of this study is to determine the maximum tolerated dose of the investigational drug and docetaxel given in addition to radiation therapy. Effectiveness and side effects of the drugs combined with radiation will also be monitored.
ELIGIBILITY
  1. Histologically or cytologically confirmed local advanced (Stage III or IV) squamous cell carcinoma of the head and neck without distant metastatic disease
  2. Measurable disease
  3. 18 years of age or older
  4. ECOG performance status of 0, 1, or 2
  5. Normal organ and bone marrow function
  6. Period of 5 years has elapsed since treatment of any previous cancer except skin cancer or CIS of cervix
  7. No clinically significant heart disease
  8. Nor prior chemotherapy or radiation therapy
  9. No brain metastases
  10. Not HIV positive
CONTACT Sue Flick RN 216-844-5071
 
TITLE CWRU 2Y97: Mutant MGM Gene Transfer Into Human Hematopoietic Progenitors to Protect Hematopoiesis During O6-Benzylguanine (BG) and BCNU Therapy of Advanced Solid Tumors
DESCRIPTION This study will evaluate the feasibility of introducing and expressing mutant-MGMT-G156A cDNA in hematopoietic progenitors taken from advanced solid tumor patients using a safety modified retroviral vector MFG.  Patients will receive cytokine injection followed by peripheral stem cell collection.  Stem cells will then undergo retroviral gene transfer of MGMT into CD34+ cells in the CWRU Cell and Gene Therapy Facility.  Patients will receive a preparative regimen of non-myeloablative BG and BCNU followed by reinfusion of MGMT transduced CD34+ cells.  On days +42, +84, +126 and +168, patients will receive repeated cycles of BG and BCNU therapy.
ELIGIBILITY
  1. Patients with any evaluable or measurable advanced solid tumor as well as glioma and non-Hodgkin’s lymphoma for whom no curative surgical, radiation therapy or chemotherapy treatment programs are available and standard therapy offers at best a modest clinical benefit.  Patients with primary and metastatic CNS malignancies are eligible.

  2. Patients must be between 18 and 70 years of age.

  3. Patients must not have had more than two prior chemotherapy regimens for metastatic disease.  Thalidomide and other non-classical non-myelosuppressive agents are not included amongst the regimens.

  4. All prior myelosuppressive therapy must have been completed 4 weeks prior to enrollment.

  5. Patients must have a life expectancy of at least 12 weeks.

  6. Patients must have adequate bone marrow, renal, hepatic, cardiac and pulmonary function.

  7. Patients must have histologically negative bone marrow biopsy.

CONTACT Anne Ness RN 216-844-1637

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