Chemotherapy in Treating Patients With Recurrent Malignant Glioma
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.
연구 개요
상세 설명
OBJECTIVES:
- Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine.
- Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma.
OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.
Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.
Patients are evaluated after every 6 week cycle.
PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Tennessee
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Memphis, Tennessee, 미국, 38105-2794
- Saint Jude Children's Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically proven recurrent primary malignant glioma
- Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance Status:
- Karnofsky at least 60%
Hematopoietic:
- Hematocrit greater than 29%
- ANC greater than 1,500/mm^3
- Platelet count greater than 125,000/mm^3
Hepatic:
- SGOT less than 1.5 times upper limit of normal (ULN)
- Bilirubin less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 mg/dL
- BUN less than 25 mg/dL
Other:
- Not pregnant
- Effective contraceptive method must be used for the duration of the study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy within 6 weeks of study
- No prior topotecan or carmustine treatment failure
- No more than 1 prior chemotherapy regimen
Endocrine therapy:
- Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level
Radiotherapy:
- No prior radiotherapy within 6 weeks of study
Surgery:
- No prior surgical resection within 3 weeks of study
Other:
- No concurrent medication that may interfere with study results
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
스폰서
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0224
- DUMC-000224-01-1R4
- DUMC-000224-00-2R3
- DUMC-0348-99-2R2
- DUMC-223-97-2
- DUMC-229-98-2R1
- SB-DUMC-229-98-2R1
- NCI-G97-1242
- CDR0000065521 (기타 식별자: NCI)
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