NCT00037037UnknownPhase 1
A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
Herbert Irving Comprehensive Cancer Center1 site in 1 countryStarted: October 1, 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Locations
- 1
Study Overview
Brief Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.
Detailed Description
OBJECTIVES:
- Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma.
- Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens.
- Compare tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6.
- Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days.
Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed high-risk stage III or IV melanoma
- •Stage III disease less than 6 months after surgical resection
- •Completed prior interferon alfa therapy OR
- •Progressive disease or major adverse events during prior interferon alfa therapy
- •Stage III disease at least 6 months after surgical resection
- •Declined, failed, or completed prior standard therapy
- •Stage IV disease
- •Declined, failed, or completed prior standard therapy
- •HLA-A2 positive
- •No CNS metastases unless treated and stable
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm3
- •Lymphocyte count at least 500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)
- •No bleeding disorder
- •Bilirubin no greater than 2.0 mg/dL
- •No hepatitis B or C positivity
- •Creatinine no greater than 1.8 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •HIV negative
- •No other serious illness
- •No serious infection requiring antibiotics
- •No history of immunodeficiency disease or autoimmune disease
- •No psychiatric or addictive disorder that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •No prior bone marrow or stem cell transplantation
- •At least 4 weeks since prior immunotherapy or biologic therapy
- •No other concurrent immunotherapy or biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent systemic corticosteroids
- •No concurrent steroids except topical or inhalational steroids
- •Concurrent hormonal therapy allowed
- •Radiotherapy:
- +8 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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