- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00389090
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
연구 개요
상세 설명
This open-label, multicenter, phase II trial will assess the antitumor activity and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be enrolled in this study. Total accrual on this study will not exceed 116 patients. The patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning immediately after the first bolus infusion and continuing until immediately prior to the last bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients may receive treatment at the same dose level until appearance of significant treatment-related toxicities, disease progression or withdrawal of consent.
Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for the duration of therapy, using physical and neurological examinations and diagnostic imaging.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90033
- AOI Pharmaceuticals Investigative Site
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Florida
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Orlando, Florida, 미국, 32804
- AOI Pharmaceuticals Investigative Site
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Illinois
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Chicago, Illinois, 미국, 60611
- AOI Pharmaceuticals Investigative Site
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Evanston, Illinois, 미국, 60201
- AOI Pharmaceuticals Investigative Site
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Kentucky
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Lexington, Kentucky, 미국, 40536
- AOI Pharmaceuticals Investigative Site
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Louisville, Kentucky, 미국, 40202
- AOI Pharmaceuticals Investigative Site
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Minnesota
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Minneapolis, Minnesota, 미국, 54407
- AOI Pharmaceuticals Investigative Site
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North Carolina
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Durham, North Carolina, 미국, 27710
- AOI Pharmaceuticals Investigative Site
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South Carolina
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Greenville, South Carolina, 미국, 29605
- AOI Pharmaceuticals Investigative Site
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Texas
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Dallas, Texas, 미국, 75246
- AOI Pharmaceuticals Investigative Site
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Houston, Texas, 미국, 77024
- AOI Pharmaceuticals Investigative Site
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Utah
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Salt Lake City, Utah, 미국, 84132
- AOI Pharmaceuticals Investigative Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
- Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
- Disease progression >= 12 weeks after the completion of any radiotherapy.
- If patient received chemotherapy or an investigational agent as part of their prior therapy, the patient must recover from all toxicities (<= Grade 1) prior to enrollment on this protocol.
- Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
- If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
- KPS >= 70%.
The following laboratory results:
- Absolute neutrophil count >= 1500 cells/microliter
- Platelet count >= 100,000 cells/microliter
- SGOT <= 2.5 x ULN
- Serum creatinine <= 1.5 x ULN
- Signed informed consent approved by Institutional Review Board.
- If sexually active, patients will take contraceptive measures for the duration of the treatment.
- For patients on corticosteroids, they must have been on a stable dose 1 week prior to baseline MRI and the dose should not be escalated over entry dose level, if clinically possible.
Exclusion Criteria:
- Pregnant or breast feeding women.
- Prior treatment with O6-BG plus temozolomide in combination.
- Active infection requiring intravenous antibiotics.
- Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients unwilling or unable to comply with the protocol.
- Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
- Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Temozolomide + O6BG
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O6BG + Temozolomide
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
best objective response rate
기간: Month 1, 2 and every 2 months thereafter.
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Month 1, 2 and every 2 months thereafter.
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2차 결과 측정
결과 측정 |
기간 |
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Safety Assessment
기간: Month 1, 2 and every 2 months thereafter
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Month 1, 2 and every 2 months thereafter
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progression-free survival
기간: every 6 months
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every 6 months
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overall survival
기간: every 6 months
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every 6 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Jennifer Quinn, MD, Preston Robert Tisch Brain Tumor Center at Duke
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
- O6BG 202
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