Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.
Detailed description
OBJECTIVES: * Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2). * Compare the immune response in patients before and after treatment with these regimens. * Compare the toxicity profile of these regimens in these patients. OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts. * Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.) * Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.) * Cohort 3 (for patients in need of immediate interleukin-2 \[IL-2\] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM\* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. NOTE: \*The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2 * Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy. PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.
Interventions
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed standard treatment * Measurable disease * HLA-A-201 positive PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 90,000/mm\^3 * No coagulation disorders Hepatic: * Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT \< 2 times normal * Hepatitis B surface antigen negative Renal: * Creatinine ≤ 2.0 mg/dL Cardiovascular: * No major cardiovascular disease * No cardiac ischemia by a stress thallium test or other comparable test\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*In order to be eligible to receive interleukin-2 (IL-2) Pulmonary: * No major respiratory disease * No obstructive or restrictive pulmonary disease\* NOTE: \*In order to be eligible to receive IL-2 Immunologic: * No autoimmune disease * No known immunodeficiency disease * No primary or secondary immunodeficiency * No allergy to eggs * No active systemic infections * HIV negative Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other active major medical illness\* NOTE: \*In order to be eligible to receive IL-2 PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior gp100 vaccination Chemotherapy: * Not specified Endocrine therapy: * No concurrent steroids Radiotherapy: * Not specified Surgery: * Prior surgery for the malignancy allowed Other: * At least 3 weeks since other prior therapy for the malignancy
Countries
United States
Outcome results
None listed