Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells 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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow or peripheral blood stem cell transplantation, and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors.
- Determine the safety and toxicity of this regimen in these patients.
- Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen.
OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until peripheral blood stem cell (PBSC) or bone marrow collection is completed.
After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after the last vaccination, patients undergo a second leukapheresis to collect lymphocytes.
After completion of the second leukapheresis, patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1 hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every other day for 10 days.
Patients are followed at 18, 24, 36, 40, and 52 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed active recurrent or refractory primary high-grade brain tumor
- Tumor must be surgically accessible
Bidimensionally measurable disease by clinical exam, CT scan, or x-ray
- Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy
- Previously treated metastatic bony lesions are not considered measurable
- No previously irradiated metastatic disease site unless no response or clear progression on imaging
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- CALGB 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Liver function less than 2.5 times normal unless due to disease
- No active hepatitis B or C
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram
- Electrocardiogram normal
Pulmonary:
- FEV1 and DLCO greater than 50% predicted OR
- Clearance by pulmonologist
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study
- Able to be weaned off steroids after surgery
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Recovered from prior conventional chemotherapy
Endocrine therapy:
- No concurrent steroid therapy for mass effect
Radiotherapy:
- See Disease Characteristics
- Recovered from prior conventional radiotherapy
Surgery:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 의자: Esteban Abella, MD, Barbara Ann Karmanos Cancer Institute
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
- 어린 시절 고급 대뇌 성상 세포종
- 성인 교모세포종
- 성인 거대 세포 교모세포종
- 성인 교육종
- 재발성 성인 뇌종양
- 성인 역형성 성상세포종
- 성인 역형성 상의세포종
- 성인 뇌간 신경교종
- 성인 중추 신경계 생식 세포 종양
- 성인 맥락총 종양
- 성인 상의모세포종
- 성인 수모세포종
- 성인 등급 III 수막종
- 성인 혼합 신경교종
- 소아 천막하 뇌실막종
- 어린 시절 천막상 뇌실막종
- 재발성 아동기 천막상원시신경외배엽종양
- 재발 성 소아 대뇌 성상 세포종
- 재발성 소아기 상의세포종
- 재발성 소아기 뇌간 신경아교종
- 재발성 소아 수모세포종
- 소아기 중추 신경계 생식 세포 종양
- 소아 맥락총 종양
- 유년기 III 등급 수막종
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000068559
- P30CA022453 (미국 NIH 보조금/계약)
- WSU-D-1654
- WSU-07-92-98-P04-FB (기타 식별자: Wayne State University - Human Investigation Committee)
- NCI-G01-1937
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