Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
Bevacizumab in Combination With Irinotecan for Malignant Gliomas
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumors cells.
PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
Secondary
- Determine the activity of this regimen, in terms of progression-free survival, in these patients.
OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke Comprehensive 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
DISEASE CHARACTERISTICS:
Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy
- Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan
- Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hematocrit > 29%
- Absolute neutrophil count > 1,500/mm^3
- Platelets > 125,000/mm^3
- Serum SGOT and bilirubin < 1.5 times upper limit of normal
- Creatinine < 1.5 mg/dL
- Urine protein:creatinine ratio ≤ 1.0
- Blood pressure ≤ 150/100 mmHg
- No unstable angina
- No New York Heart Association class II or greater congestive heart failure
- No myocardial infarction within the past 6 months
- No stroke within the past 6 months
- No clinically significant peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression
- At least 6 weeks since prior surgical resection
- No previous major surgical procedures or open biopsies within 28 days prior to study entry
- No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry
- No anticipated need for major surgical procedures during the course of the study
- No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel
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
- マスキング:なし(オープンラベル)
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 |
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安全性
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Activity in terms of progression-free survival
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協力者と研究者
スポンサー
捜査官
- スタディチェア:James J. Vredenburgh, MD、Duke Cancer Institute
出版物と役立つリンク
一般刊行物
- Desjardins A, Reardon DA, Herndon JE 2nd, Marcello J, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Bailey L, Bigner DD, Friedman AH, Friedman HS, Vredenburgh JJ. Bevacizumab plus irinotecan in recurrent WHO grade 3 malignant gliomas. Clin Cancer Res. 2008 Nov 1;14(21):7068-73. doi: 10.1158/1078-0432.CCR-08-0260.
- Sathornsumetee S, Cao Y, Marcello JE, Herndon JE 2nd, McLendon RE, Desjardins A, Friedman HS, Dewhirst MW, Vredenburgh JJ, Rich JN. Tumor angiogenic and hypoxic profiles predict radiographic response and survival in malignant astrocytoma patients treated with bevacizumab and irinotecan. J Clin Oncol. 2008 Jan 10;26(2):271-8. doi: 10.1200/JCO.2007.13.3652.
- Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Dowell JM, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Wagner M, Bigner DD, Friedman AH, Friedman HS. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res. 2007 Feb 15;13(4):1253-9. doi: 10.1158/1078-0432.CCR-06-2309.
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 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
イリノテカン塩酸塩の臨床試験
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University of CologneServier募集
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Massachusetts General HospitalStand Up To Cancer募集