Status:
COMPLETED
Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 interleuk...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00091338
Start Date
August 1 2004
Last Update
April 30 2015
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182