Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
연구 개요
상세 설명
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Assess the activity of this regimen in these patients.
- Estimate peripheral blood carmustine levels in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)
Additional patients then receive treatment with DTI-015 at the recommended phase II dose.
Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression.
PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
California
-
Los Angeles, California, 미국, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
San Francisco, California, 미국, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
-
Stanford, California, 미국, 94305-5408
- Stanford University Medical Center
-
-
Colorado
-
Denver, Colorado, 미국, 80262
- University of Colorado Cancer Center
-
-
Florida
-
Tampa, Florida, 미국, 33612-9416
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
-
-
Illinois
-
Evanston, Illinois, 미국, 60201
- Evanston Northwestern Health Care
-
-
New Jersey
-
Edison, New Jersey, 미국, 08820
- John F. Kennedy Medical Center
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45219
- Barrett Cancer Center
-
-
Texas
-
Houston, Texas, 미국, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
-
Virginia
-
Richmond, Virginia, 미국, 23298-0631
- Massey Cancer Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically proven supratentorial malignant glioblastoma multiforme
- Clear evidence of disease progression by MRI
- Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
- Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
- No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
- No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
- No tumor extension into the ventricular system
- Tumor volume no greater than 33.4 cm3
- At least one prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No evidence of bleeding diathesis
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 40 mL/min
- BUN no greater than 30 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled infection
- Afebrile unless fever due to presence of tumor
- No other concurrent serious medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No prior intracranial brachytherapy
Surgery:
- Recovered from any prior surgery
Other:
- No prior anticoagulants
- No other concurrent investigational agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Gene David Resnick, MD, Millennix
연구 기록 날짜
연구 주요 날짜
연구 시작
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
- CDR0000068207
- DTI-9901
- UCMC-00042402
- NCI-V00-1623
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. .