Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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