Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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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).
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Compare the immune response in patients before and after treatment with these regimens.
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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.
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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.)
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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.)
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically proven metastatic melanoma that has failed standard treatment
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Measurable disease
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HLA-A-201 positive
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
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WBC ≥ 3,000/mm^3
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Platelet count ≥ 90,000/mm^3
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No coagulation disorders
Hepatic:
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Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
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AST/ALT < 2 times normal
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Hepatitis B surface antigen negative
Renal:
- Creatinine ≤ 2.0 mg/dL
Cardiovascular:
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No major cardiovascular disease
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No cardiac ischemia by a stress thallium test or other comparable test*
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No myocardial infarction*
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No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)
Pulmonary:
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No major respiratory disease
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No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2
Immunologic:
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No autoimmune disease
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No known immunodeficiency disease
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No primary or secondary immunodeficiency
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No allergy to eggs
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No active systemic infections
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HIV negative
Other:
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Not pregnant
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Negative pregnancy test
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Fertile patients must use effective contraception
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | United States | 20892-1182 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Study Chair: Steven A. Rosenberg, MD, PhD, NCI - Surgery Branch
Study Documents (Full-Text)
None provided.More Information
Publications
- CDR0000066961
- NCI-99-C-0044
- NCI-T98-0088
- NCT00001800