Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment
Study Details
Study Description
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy 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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Determine the clinical responses in patients with HLA-A0201-positive refractory metastatic melanoma treated with tyrosinase-related protein-2:180-188 peptide vaccine alone.
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Determine the clinical response rate of patients who have an immediate need to receive interleukin-2 (IL-2) in addition to this vaccine.
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Compare the immunologic response, in terms of changes in T-cell precursors before and after treatment, in patients treated with this vaccine with or without IL-2.
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Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a randomized, open-label study.
Patients who need immediate interleukin-2 (IL-2) receive tyrosinase-related protein-2 (TRP-2):180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2 IV over 15 minutes once every 8 hours on days 2-5. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms.
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Arm I: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51 subcutaneously (SC) on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
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Arm II: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51 SC once weekly on weeks 1-4. Treatment repeats every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who have a complete response (CR) receive 1 additional course after achieving CR. Patients who have progressive disease while receiving vaccine alone may cross over to receive peptide vaccine with IL-2 for at least 2 courses.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A maximum of 83 patients (19-33 who need immediate interleukin-2 (IL-2); 15-25 per treatment arm who do not need immediate IL-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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Diagnosis of metastatic melanoma
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Refractory to standard therapy
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No resectable locoregional disease
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HLA-A0201 positive
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Measurable disease
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Previously resected brain metastases, brain metastases stable after prior radiosurgery, or brain metastases less than 1 cm and without edema allowed
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
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WBC at least 3,000/mm^3
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Platelet count at least 90,000/mm^3
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No coagulation disorders
Hepatic:
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Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
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AST/ALT less than 3 times normal
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Hepatitis B surface antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
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No major medical illness of the cardiovascular system
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No cardiac ischemia*
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No myocardial infarction*
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No cardiac arrhythmias* NOTE: * For interleukin-2 (IL-2) administration
Pulmonary:
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No major medical illness of the respiratory system
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No obstructive or restrictive pulmonary disease (for IL-2 administration)
Immunologic:
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HIV negative
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No primary or secondary immunodeficiency
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No known immunodeficiency disease
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No autoimmune disease
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No active systemic infections
Other:
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Not pregnant
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Negative pregnancy test
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
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At least 3 weeks since prior biologic therapy for melanoma
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No prior immunization to tyrosinase-related protein-2 antigen
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No other concurrent biologic therapy for melanoma
Chemotherapy:
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At least 3 weeks since prior chemotherapy for melanoma and recovered
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No concurrent chemotherapy for melanoma
Endocrine therapy:
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At least 3 weeks since prior endocrine therapy for melanoma
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No concurrent systemic steroid therapy
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No concurrent endocrine therapy for melanoma
Radiotherapy:
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See Disease Characteristics
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At least 3 weeks since prior radiotherapy for melanoma and recovered
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No concurrent radiotherapy for melanoma
Surgery:
- See Disease Characteristics
Other:
- No other concurrent therapy for melanoma
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
None provided.- CDR0000068818
- NCI-01-C-0193
- NCI-5369
- NCT00017849