Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Brief Summary

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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage II, stage III, or stage IV melanoma.

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Detailed Description

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OBJECTIVES: I. Determine the safety and the maximum tolerated dose of vaccines containing two adenoviral vectors encoding the melanoma antigens Melan-A/MART-1 and gp100 in patients with stage II-IV melanoma. II. Assess the dose-response changes in the frequency of MART-1 and gp100 reactive T cells (CD4+ and CD8+) in patients receiving one of three different vaccine regimens. III. Assess the T-cell response to one melanoma antigen following three treatments with the other antigen in these patients. IV. Assess the effect of concomitant vaccination with both antigens on T-cell response in these patients.

OUTLINE: This is a dose escalation study. Patients are sequentially enrolled on 1 of 3 treatment arms. Each treatment arm has 3 groups. Arm I: Patients receive Ad2/MART-1v2 vaccine and Ad2/gp100v2 vaccine intradermally (ID) at the lowest dose level once every three weeks for either 6 or 15 weeks depending on assignment. Arm II: Patients receive Ad2/gp100v2 vaccine and Ad2/MART-1v2 vaccine ID at the mid-range dose level once every three weeks for either 6 or 15 weeks depending on assignment. Arm III: Patients receive Ad2/MART-1v2 vaccine and Ad2/gp100v2 vaccine ID at the highest dose level once every three weeks for either 6 or 15 weeks depending on assignment. Cohorts of 3-6 patients receive escalating doses of Ad2/MART-1v2 and/or Ad2/gp100v2 vaccines in each arm until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 months, 6 months, and 1 year after completion of treatment.

PROJECTED ACCRUAL: A total of 24-36 patients will be accrued over 1 year.

Conditions

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Melanoma (Skin)

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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MART-1 antigen

Intervention Type BIOLOGICAL

gp100 antigen

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV cutaneous malignant melanoma No evidence of disease at time of entry to protocol Definitive complete surgical resection within past 12 months HLA-A2 positive

PATIENT CHARACTERISTICS: Age: 18 or over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000 cells/mm3 Platelet count at least 100,000 cells/mm3 No clinically significant hematologic disease that would preclude study Hepatic: SGOT and SGPT less than 2 times upper limit of normal Bilirubin less than 2 mg/dL No clinically significant hepatic disease that would preclude study Renal: Creatinine less than 2 mg/dL No clinically significant renal disease that would preclude study Cardiovascular: No clinically significant cardiac disease that would preclude study Other: No clinically significant underlying condition that would preclude study No significant autoimmune disease or other major immune system disorder HIV negative HTLV negative Hepatitis B and C negative No active infection requiring parenteral antibiotics No psychiatric disorder that could hinder protocol compliance Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy At least 3 months since prior interferon therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: No prior or concurrent immunosuppressants Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery Other: No other prior or concurrent experimental anticancer therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No