A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, United StatesSee the location