COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma
RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy.
연구 개요
상세 설명
OBJECTIVES:
- Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme.
- Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics.
- Determine the response rate, disease free survival, and survival in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study of COL-3. Patients are stratified by anticonvulsant (anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant).
- Phase I: Patients receive oral COL-3 daily. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
- Phase II: Patients receive oral COL-3 daily at the MTD from the phase I portion of this study.
Patients are followed every 2 months until death.
PROJECTED ACCRUAL: A total of 15-18 patients will be accrued for phase I of the study and a total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per month.
연구 유형
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
Florida
-
Tampa, Florida, 미국, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
-
-
Maryland
-
Baltimore, Maryland, 미국, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
-
-
North Carolina
-
Winston-Salem, North Carolina, 미국, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104-4283
- University of Pennsylvania Cancer Center
-
-
Texas
-
San Antonio, Texas, 미국, 78284-7811
- University of Texas Health Science Center at San Antonio
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically proven high grade glioma that is progressive or recurrent following radiotherapy or chemotherapy
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Prior low grade glioma that has progressed to high grade glioma following radiotherapy and/or chemotherapy allowed
- Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
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
Hepatic:
- Bilirubin normal
- SGOT or SGPT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No myocardial infarction, stroke, or congestive heart failure within the past 3 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study
- No serious active infection or medical illness that would preclude compliance
- HIV negative
- No history of gastrointestinal disorders that would interfere with absorption of study drug
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, or basal cell or squamous cell skin cancer
- No hypersensitivity to tetracyclines or its derivatives
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF)
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas) and recovered
- No more than 2 prior chemotherapy regimens
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior large field radiotherapy (greater than 20% of total bone marrow)
- At least 3 months since other prior radiotherapy and recovered
Surgery:
- No prior major upper gastrointestinal surgery
- At least 14 days since other prior major surgery
Other:
- No other concurrent investigational agents
- No prolonged sun exposure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Pamela Z. New, MD, The University of Texas Health Science Center at San Antonio
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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
기타 연구 ID 번호
- CDR0000067379
- NABTT-9809
- JHOC-NABTT-9809
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. .