Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Biological: gp100 antigen; Biological: aldesleukin; Biological: fowlpox virus vaccine vector

Study type: Interventional

Funder types: NIH

Identifiers

NCT00019669

CDR0000066961

NCI-T98-0088

NCI-99-C-0044

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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