Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
A Phase II Evaluation With Correlative Studies Of Fenretinide (NSC 374551-4HPR) As A Single Agent In The Treatment Of Adult Patients With Recurrent Glioblastoma Multiforme
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Compare the efficacy of neoadjuvant and adjuvant fenretinide vs adjuvant fenretinide alone, in terms of 6-month progression-free survival, in patients with recurrent glioblastoma multiforme undergoing surgical resection II. Correlate the serum and glioma tissue pharmacology of this drug with clinical response in patients treated with these regimens.
III. Determine whether this drug induces apoptosis in glioma tissue in patients treated with these regimens.
IV. Correlate the apoptotic index with tissue and serum concentration and clinical response in patients treated with these regimens.
V. Compare radiological response, overall survival, and unexpected toxicity in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.
Arm II: Patients undergo surgical resection.
Beginning two weeks after surgery, all patients receive adjuvant oral fenretinide twice daily on weeks 1 and 4. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-46 patients (10-23 per treatment arm) will be accrued for this study within 7-46 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed glioblastoma multiforme after initial tumor resection
Radiologically evident recurrent tumor after prior radiotherapy OR after treatment for no more than 2 prior relapses
- Enhancing or nonenhancing recurrent disease by MRI
- No progressive symptoms requiring urgent surgery
- Performance status - Karnofsky 70-100%
- More than 8 weeks
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- PT/PTT no greater than upper limit of normal
- SGPT no greater than 2.5 times normal
- Alkaline phosphatase no greater than 2.5 times normal
- Bilirubin less than 1.5 mg/dL
- BUN no greater than 1.5 times normal
- Creatinine no greater than 1.5 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 2 months after study participation
- Amylase and lipase normal
- No active infection
- No other disease that would obscure toxicity or dangerously alter drug metabolism
- No other concurrent serious medical illness
- Not at risk from any study treatment delays
- Able to swallow fenretinide capsules
- Recovered from all prior chemotherapy
- Approximately 2 weeks since prior vincristine
- Approximately 6 weeks since prior nitrosoureas
- Approximately 3 weeks since prior procarbazine
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- See Disease Characteristics
- At least 1 week since prior vitamin A
- At least 1 week since prior isotretinoin (Accutane®)
- No concurrent vitamin A during and for 2 weeks after study participation
- No concurrent antioxidants (e.g., ascorbic acid or vitamin E)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Arm I (fenretinide, surgery)
Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.
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상관 연구
상관 연구
다른 이름들:
수술을 받다
구두로 주어진
다른 이름들:
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활성 비교기: Arm II (surgery)
Patients undergo surgical resection.
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상관 연구
상관 연구
다른 이름들:
수술을 받다
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Progression-free survival (PFS)
기간: Up to 6 months
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Up to 6 months
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Plasma and tissue concentrations of fenretinide and its metabolite, 4-MPR using high-performance liquid chromatography (HPLC) assay
기간: At baseline, and at 1, 7, 14, and 21 days
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At baseline, and at 1, 7, 14, and 21 days
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Tumor apoptotic index after fenretinide treatment by immunohistochemistry
기간: At the time of surgery
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At the time of surgery
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Correlation between tumor apoptotic index with serum and tissue fenretinide levels
기간: At the time of surgery
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At the time of surgery
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Correlation of time to progression with drug levels and apoptotic index
기간: Up to 2 years
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Up to 2 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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전반적인 생존
기간: 최대 2년
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최대 2년
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Fenretinide effects on retinol, RBP, retinoid receptor levels and IGF-1
기간: Up to 21 days (course 1 and 4)
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Up to 21 days (course 1 and 4)
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Fenretinide activity using magnetic resonance spectroscopy (MRS)
기간: At the time of surgery
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At the time of surgery
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Radiological response
기간: Up to 2 years
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Up to 2 years
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Unexpected toxicity associated with fenretinide as assessed by CTC version 3.0
기간: Up to 2 years
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Up to 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vinay K. Puduvalli, M.D. Anderson Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료
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
- NCI-2012-02566
- ID02-701
- R21CA097767 (미국 NIH 보조금/계약)
- CDR0000346722 (레지스트리 식별자: PDQ (Physician Data Query))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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