- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00003463
Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
연구 개요
상세 설명
OBJECTIVES:
- Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.
- Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients.
OUTLINE: This is a dose escalation study.
All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity.
Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT.
Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression.
Patients are followed for at least 4 months.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.
연구 유형
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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참여기준
자격 기준
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연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
- Must be able to undergo surgical resection
- At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers
- Not requiring immediate radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Greater than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 125,000/mm^3
- Hematocrit at least 29%
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT less than 2.5 times ULN
- Alkaline phosphatase less than 2 times ULN
Renal:
- BUN less than 1.5 times ULN
- Creatinine less than 1.5 times ULN
Neurological:
- Must be neurologically stable
Other:
HIV negative
- No AIDS-related illness
- No nonmalignant systemic disease that would make patient a poor medical risk
- No acute infection requiring intravenous antibiotics
Not pregnant or nursing
- Negative pregnancy test 24 hours prior to study
- Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior irinotecan
- At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy
Endocrine therapy:
- At least 1 week of nonincreasing dose of steroids prior to study
Radiotherapy:
- At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0901 (Ethikkommision KiKli BE)
- DUMC-0901-02-5R4
- DUMC-0901-02-5R2
- DUMC-000901-00-5R2
- DUMC-000901-01-5R3
- DUMC-0797-99-5RI
- DUMC-796-98-5
- DUMC-98065
- UCLA-9812060
- NCI-G98-1464
- DUMC-0901-01-5R3
- CDR0000066497 (기타 식별자: NCI)
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