Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.
- Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.
Secondary
- Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.
- Determine the development of tumor immunity in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of GM-K562.
Patients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.
Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 20 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana Farber Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia
- Chronic phase disease
- Philadelphia chromosome positive disease
Disease in first complete hematologic response, defined by all of the following:
- Complete normalization of peripheral blood counts with WBC < 10,000/mm^3
- Platelet count < 450,000/mm^3
- No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
Persistent molecular evidence of disease
- Detectable BCR-ABL transcript by quantitative polymerase chain reaction
- Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
- Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- No known HIV
- ALT or AST ≤ 3 times upper limit of normal
- Oxygen saturation ≥ 93% at room air
- No history of recent acute myocardial infarction
- No history of unstable angina
- No pulmonary decomposition requiring hospitalization within the past 3 months
- No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior allogeneic stem cell transplantation
- At least 2 months since other prior experimental therapy
- At least 6 months since prior participation in another vaccine study
- No concurrent systemic immunosuppressive medication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety and Toxicity
기간: 3 years
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To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disease Response
기간: 3 years
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To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements
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3 years
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Tumor immunity
기간: 3 years
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To characterize the development of tumor immunity in response to vaccination with GM-K562 cells
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3 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 04-126
- P30CA006516 (미국 NIH 보조금/계약)
- R21CA115043 (미국 NIH 보조금/계약)
- CDR0000456445 (레지스트리 식별자: NCI PDQ)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
GM-K562 cell vaccine에 대한 임상 시험
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Dana-Farber Cancer InstituteNational Institutes of Health (NIH); Brigham and Women's Hospital완전한급성 골수성 백혈병 | 만성골수단구성백혈병 | 골수이형성 증후군-과도한 모세포를 동반한 불응성 빈혈미국
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Alliance for Cancer Gene Therapy종료됨
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Dana-Farber Cancer InstituteBrigham and Women's Hospital완전한
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)완전한
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David AviganThe V Foundation모병