Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining monoclonal antibody therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy with interleukin-2 in treating patients who have metastatic melanoma.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose (MTD) of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) in combination with high-dose interleukin-2 (IL-2) in patients with metastatic melanoma. (Phase I is closed to accrual as of 4/13/2004). - Determine the activity of MDX-CTLA4 administered at the MTD with high-dose IL-2 in these patients. - Determine whether the administration of IL-2 alters the pharmacokinetics of MDX-CTLA4 in these patients. - Determine the safety and adverse event profile of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4). - Phase I: Patients receive MDX-CTLA4 IV on days 0, 21, and 42. Patients also receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours for up to 15 doses beginning on days 22 and 43. Treatment repeats every 63 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response and no greater than grade 1 toxicity may receive additional courses of therapy. Patients who require discontinuation of MDX-CTLA4 due to toxicity may continue receiving IL-2 at the discretion of the investigator. Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Phase I is closed to accrual as of 4/13/2004). - Phase II: Patients receive treatment as in phase I at the MTD of MDX-CTLA4. Patients who achieve a partial or complete response and later develop recurrent or progressive disease may be retreated at the same dose. Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-51 patients (3-18 for phase I and 19-33 for phase II) will be accrued for this study within 1 year. (Phase I is closed to accrual as of 4/13/2004).


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed stage IV melanoma - Mucosal or ocular melanoma also eligible - Clinically evaluable disease - At least 1 site of measurable disease PATIENT CHARACTERISTICS: Age - 16 and over Performance status - ECOG 0-1 Life expectancy - At least 3 months Hematopoietic - WBC at least 2,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - Hematocrit at least 30% Hepatic - Bilirubin no greater than upper limit of normal (ULN)* (less than 3.0 mg/dL in patients with Gilbert's syndrome) - AST no greater than 3 times ULN* - Hepatitis B surface antigen negative - Hepatitis C antibody nonreactive - No evidence or history of significant hepatic disease that would preclude safe administration of high-dose IL-2 NOTE: *Unless attributable to disease Renal - Creatinine no greater than 2.0 mg/dL - No evidence or history of significant renal disease that would preclude safe administration of high-dose IL-2 Cardiovascular - No evidence or history of significant cardiac disease that would preclude safe administration of high-dose IL-2 - Thallium stress test normal (for patients over 50 years of age or with a history of cardiovascular disease) Pulmonary - No evidence or history of significant pulmonary disease that would preclude safe administration of high-dose IL-2 Immunologic - HIV negative - No autoimmune disease (including uveitis and autoimmune inflammatory eye disease) - No active infection Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix - No evidence or history of significant gastrointestinal disease that would preclude safe administration of high-dose IL-2 - No evidence or history of psychiatric disease that would preclude safe administration of high-dose IL-2 - No other underlying medical condition that would make the administration of the study drug hazardous or obscure the interpretation of adverse events - No other concurrent medical condition that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 weeks since prior immunotherapy for melanoma and recovered - No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) - No prior high-dose (at least 600,000 IU/kg every 8 hours) interleukin-2 (IL-2) Chemotherapy - At least 3 weeks since prior chemotherapy for melanoma and recovered - No concurrent chemotherapy Endocrine therapy - At least 3 weeks since prior hormonal therapy for melanoma and recovered - At least 4 weeks since prior corticosteroids - No concurrent systemic or topical corticosteroids Radiotherapy - At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery - Not specified Other - No concurrent immunosuppressive agents (e.g., cyclosporine or its analog)


NCT ID:

NCT00058279


Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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