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Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Study of Subcutaneous CYT 99 007 (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00091338
Enrollment
Unknown
Registered
2004-09-09
Start date
2004-08-31
Completion date
Unknown
Last updated
2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma, stage IV melanoma

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALMART-1 antigen
BIOLOGICALgp100 antigen
BIOLOGICALincomplete Freund's adjuvant

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026