Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
Full description
OBJECTIVES:
Primary
- Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in patients with stage IIB, IIC, III, or IV melanoma.
- Determine the maximum tolerated dose of this regimen in these patients.
- Compare the antibody and T-cell response in patients treated with two different vaccination schedules.
Secondary
- Assess antitumor response in patients treated with this regimen.
OUTLINE: This is a randomized, crossover, dose-escalation study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
- Arm II: Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-9 patients (at least 3 per treatment arm) receive escalating doses of human and mouse gp100 DNA vaccines until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 3 weeks and then annually for 15 years.
PROJECTED ACCRUAL: Approximately 18-27 patients will be accrued for this study within 6-9 months.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignant melanoma
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Stage IIB, IIC, III, or IV disease
- Patients with stage III or IV disease who are free of disease after surgical resection* are eligible
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Patients free of disease after surgical resection* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: *Patients who underwent surgical resection must have had the surgery within the past year
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HLA-A0201 positive
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No detectable brain metastases
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- No active bleeding
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Albumin ≥ 3.5 g/dL
- AST and ALT ≤ 2.5 times ULN
- Lactate dehydrogenase ≤ 2 times ULN
- No clinical history of hepatitis B or C
Renal
- Creatinine ≤ 2.0 mg/dL
Immunologic
- No clinical history of HIV
- No clinical history of HTLV-1
- No active infection requiring antibiotics within the past 72 hours
- No history of collagen vascular, rheumatologic, or other autoimmune disorder
- No grade 1 fever within the past 72 hours
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 25 kg
- No serious underlying medical condition that would preclude study participation
- No preexisting uveal or choroidal eye disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- More than 4 weeks since prior immunotherapy
- No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
- No concurrent corticosteroids that would preclude study participation
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- Recovered from all prior therapy
- No other concurrent medication that would preclude study participation
- No other concurrent investigational agents
- No other concurrent systemic therapy
Trial design
Primary purpose
Allocation
Interventional model
Masking
19 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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