Expired Study
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Bethesda, Maryland 20892


RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.

Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma. - Determine the safety of this regimen in these patients. Secondary - Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients. - Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen. - Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in these patients. OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7). Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of IL-7 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. After the MTD is determined, an additional 13 patients are treated at that dose level. Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year. PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3 months.


DISEASE CHARACTERISTICS: - Histologically confirmed melanoma - Metastatic disease - Measurable or evaluable disease - Disease progression during or after prior interleukin-2 (IL-2) OR ineligible to receive high-dose IL-2* OR has disease burden for which IL-2 is not indicated* NOTE: *If patient did not receive prior IL-2, must have progressed after prior standard first-line therapy (e.g., metastasectomy for single lesions or dacarbazine) - HLA-A*0201-positive disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count > 1,000/mm^3* - Absolute lymphocyte count ≥ 200/mm^3* - Platelet count > 100,000/mm^3 - No proliferative hematologic disease NOTE: *For 2 consecutive readings performed on 2 different days Hepatic - AST and ALT < 3 times upper limit of normal (ULN) - PT/PTT ≤ 1.5 times ULN - Hepatitis B negative - Positive hepatitis B serology indicative of prior immunization (i.e., positive for antibody against hepatitis B surface antigen AND negative for antibody against hepatitis B core antigen) allowed - Hepatitis C negative Renal - Creatinine ≤ 1.4 mg/dL Cardiovascular - Ejection fraction > 45% by MUGA for patients ≥ 50 years of age OR with a history of cardiac disease - No resting blood pressure > 140/90 mm Hg with standard antihypertensive therapy Pulmonary - DLCO/VA and FEV_1 > 50% of predicted on pulmonary function test for smokers OR for patients with clinical evidence of compromised pulmonary function - No history of severe asthma Immunologic - HIV negative - No history of autoimmune disease - No splenomegaly Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other medical or psychiatric disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 4 weeks since prior cytokines - No prior allogeneic hematopoietic stem cell transplantation - No concurrent growth factors - No concurrent monoclonal antibodies - No other concurrent immunotherapy - No other concurrent cytokines - No other concurrent biologic agents Chemotherapy - See Disease Characteristics - No prior intensive myeloablative chemotherapy - No concurrent chemotherapy Endocrine therapy - More than 2 weeks since prior systemic corticosteroids for more than 72 hours in duration - No concurrent systemic steroids Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior splenectomy - No prior solid organ transplantation Other - More than 4 weeks since prior cytotoxic therapy - No other concurrent cytotoxic therapy - No concurrent chronic anticoagulation therapy (e.g., high-dose warfarin, heparin, or aspirin) - Concurrent low-dose warfarin (1-2 mg) allowed - No concurrent chronic medication for asthma - No concurrent immunosuppressive therapy



Primary Contact:

Principal Investigator
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch

Backup Contact:


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: June 25, 2018

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