Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Assess the activity of this regimen in these patients.
- Estimate peripheral blood carmustine levels in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)
Additional patients then receive treatment with DTI-015 at the recommended phase II dose.
Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression.
PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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San Francisco、California、アメリカ、94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Stanford、California、アメリカ、94305-5408
- Stanford University Medical Center
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Colorado
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Denver、Colorado、アメリカ、80262
- University of Colorado Cancer Center
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Florida
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Tampa、Florida、アメリカ、33612-9416
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University Hospital - Atlanta
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Illinois
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Evanston、Illinois、アメリカ、60201
- Evanston Northwestern Health Care
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New Jersey
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Edison、New Jersey、アメリカ、08820
- John F. Kennedy Medical Center
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- Barrett Cancer Center
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Texas
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Houston、Texas、アメリカ、77030-4009
- University of Texas - MD Anderson Cancer Center
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Virginia
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Richmond、Virginia、アメリカ、23298-0631
- Massey Cancer Center
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin
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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 proven supratentorial malignant glioblastoma multiforme
- Clear evidence of disease progression by MRI
- Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
- Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
- No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
- No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
- No tumor extension into the ventricular system
- Tumor volume no greater than 33.4 cm3
- At least one prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
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
- No evidence of bleeding diathesis
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 40 mL/min
- BUN no greater than 30 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled infection
- Afebrile unless fever due to presence of tumor
- No other concurrent serious medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No prior intracranial brachytherapy
Surgery:
- Recovered from any prior surgery
Other:
- No prior anticoagulants
- No other concurrent investigational agents
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
協力者と研究者
スポンサー
捜査官
- スタディチェア：Gene David Resnick, MD、Millennix
研究記録日
主要日程の研究
研究開始
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。
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