Vaccine Therapy in Treating Patients With Metastatic Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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Determine whether an immunologic response can be obtained in HLA*0201-expressing patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51.
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Determine which vaccine strategy (frequency, schedule, and dosing) is best for future studies in these patients.
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Determine the toxicity of this treatment in these patients.
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Determine whether prior immunization with telomerase: 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma.
OUTLINE: This is a randomized study. Patients are stratified according to disease (metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of three treatment arms.
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Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment.
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Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3 hours at baseline, after the vaccine on week 4, and after each course of treatment.
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Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in arm II.
Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course of treatment after achieving CR.
Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms may receive interleukin-2 (IL-2) combined with vaccine as in arm II. Beginning the day after each immunization, IL-2 is administered IV over 15 minutes every 8 hours over 4 days on weeks 1, 4, 7, and 10 for a maximum of 12 doses. Patients continuing to experience disease progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined therapy.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 90-162 patients (30-54 per treatment arm; 45-81 per stratum) will be accrued for this study within less than 2 years.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Presenting with evaluable metastatic cancer
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Refractory to standard treatment OR
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Post-radiation for malignant glioma
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HLA-A*0201 expression
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
Hepatic:
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Bilirubin no greater than 1.6 mg/dL
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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 cardiac ischemia by stress thallium or comparable test*
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No prior myocardial infarction*
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No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only
Pulmonary:
- No obstructive or restrictive pulmonary disease (patients receiving IL-2 only)
Immunologic:
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HIV negative
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No autoimmune disease or any other known immunodeficiency disease
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No active primary or secondary immunodeficiency
Other:
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No other active major medical illness*
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No active systemic infection
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Not pregnant
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Negative pregnancy test
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Fertile patients must use effective contraception NOTE: *Patients receiving IL-2 only
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior telomerase: 540-548 peptide immunization
Chemotherapy:
- Recovered from prior chemotherapy
Endocrine therapy:
- No requirement for systemic steroid therapy
Radiotherapy:
-
See Disease Characteristics
-
Recovered from prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 weeks since prior systemic therapy for cancer
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.- CDR0000068756
- NCI-01-C-0176
- NCI-4970
- NCT00016640