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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Texas
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Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I (fenretinide, surgery)
Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.
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相関研究
相関研究
他の名前：
手術を受ける
経口投与
他の名前：
|
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アクティブコンパレータ：Arm II (surgery)
Patients undergo surgical resection.
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相関研究
相関研究
他の名前：
手術を受ける
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Progression-free survival (PFS)
時間枠：Up to 6 months
|
Up to 6 months
|
|
Plasma and tissue concentrations of fenretinide and its metabolite, 4-MPR using high-performance liquid chromatography (HPLC) assay
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 2 years
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Up to 2 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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全生存
時間枠：2年まで
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2年まで
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Fenretinide effects on retinol, RBP, retinoid receptor levels and IGF-1
時間枠：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)
時間枠：At the time of surgery
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At the time of surgery
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Radiological response
時間枠：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
時間枠：Up to 2 years
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Up to 2 years
|
協力者と研究者
捜査官
- 主任研究者：Vinay K. Puduvalli、M.D. Anderson Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2012-02566
- ID02-701
- R21CA097767 (米国 NIH グラント/契約)
- CDR0000346722 (レジストリ識別子：PDQ (Physician Data Query))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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