Vaccine Therapy in Treating Patients With Metastatic Cancer
Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
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.
연구 개요
상태
상세 설명
OBJECTIVES:
- 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.
- Determine which vaccine strategy (frequency, schedule, and dosing) is best for future studies in these patients.
- Determine the toxicity of this treatment in these patients.
- 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.
- 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.
- 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.
- 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.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Presenting with evaluable metastatic cancer
- Refractory to standard treatment OR
- Post-radiation for malignant glioma
- HLA-A*0201 expression
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
Hepatic:
- Bilirubin no greater than 1.6 mg/dL
- AST/ALT less than 3 times normal
- Hepatitis B surface antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No cardiac ischemia by stress thallium or comparable test*
- No prior myocardial infarction*
- No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only
Pulmonary:
- No obstructive or restrictive pulmonary disease (patients receiving IL-2 only)
Immunologic:
- HIV negative
- No autoimmune disease or any other known immunodeficiency disease
- No active primary or secondary immunodeficiency
Other:
- No other active major medical illness*
- No active systemic infection
- Not pregnant
- Negative pregnancy test
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000068756
- NCI-01-C-0176
- NCI-4970
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