Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
調査の概要
詳細な説明
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- University of Arkansas for Medical Sciences
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California
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La Jolla、California、アメリカ、92093-0658
- University of California San Diego Cancer Center
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles、California、アメリカ、91010
- Beckman Research Institute, City of Hope
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Los Angeles、California、アメリカ、90027-0700
- Children's Hospital Los Angeles
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Orange、California、アメリカ、92868
- Children's Hospital of Orange County
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Palo Alto、California、アメリカ、94304
- Lucile Packard Children's Hospital at Stanford
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San Francisco、California、アメリカ、94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington、District of Columbia、アメリカ、20010-2970
- Children's National Medical Center
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Florida
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Gainesville、Florida、アメリカ、32610-100277
- Shands Hospital and Clinics, University of Florida
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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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Chicago、Illinois、アメリカ、60614
- Children's Memorial Hospital, Chicago
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Indiana
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Indianapolis、Indiana、アメリカ、46202-5265
- Indiana University Cancer Center
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Maryland
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Baltimore、Maryland、アメリカ、21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Dana-Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02111
- Boston Floating Hospital Infants and Children
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- Mott Children's Hospital
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Detroit、Michigan、アメリカ、48201
- Children's Hospital of Michigan
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson、Mississippi、アメリカ、39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City、Missouri、アメリカ、64108
- Children's Mercy Hospital
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Saint Louis、Missouri、アメリカ、63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
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New York
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Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
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New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
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New York、New York、アメリカ、10032
- Columbia Presbyterian Hospital
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Syracuse、New York、アメリカ、13210
- State University of New York - Upstate Medical University
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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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Ohio
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Cincinnati、Ohio、アメリカ、45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Pittsburgh、Pennsylvania、アメリカ、15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston、South Carolina、アメリカ、29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis、Tennessee、アメリカ、38105-2794
- Saint Jude Children's Research Hospital
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Nashville、Tennessee、アメリカ、37232-6838
- Vanderbilt Cancer Center
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Texas
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Fort Worth、Texas、アメリカ、76104
- Cook Children's Medical Center - Fort Worth
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine
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Houston、Texas、アメリカ、77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio、Texas、アメリカ、78284-7811
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City、Utah、アメリカ、84132
- Huntsman Cancer Institute
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Washington
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Seattle、Washington、アメリカ、98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison、Wisconsin、アメリカ、53792-0001
- University of Wisconsin Hospital and Clinics
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Milwaukee、Wisconsin、アメリカ、53226
- Midwest Children's Cancer Center
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Victoria
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Parkville、Victoria、オーストラリア、3052
- Royal Children's Hospital
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Western Australia
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Perth、Western Australia、オーストラリア、6001
- Princess Margaret Hospital for Children
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Ontario
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Toronto、Ontario、カナダ、M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal、Quebec、カナダ、H3H 1P3
- Montreal Children's Hospital
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Montreal、Quebec、カナダ、H3T 1C5
- Hôpital Sainte Justine
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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 malignant solid tumor at original diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor No bone marrow metastases (for less heavily pretreated stratum only)
PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky 50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater than grade II
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 1 week since prior growth factor therapy At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not specified Other: No concurrent foods or medication that interferes with P-450 metabolism Anticonvulsants allowed
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
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他の名前：
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実験的：ECTEINASCIDIN 743 (1300 ug/m2)
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他の名前：
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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 |
|---|---|
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無増悪サバイバル
時間枠：学習期間
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学習期間
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dose Limiting Toxicity
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To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
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Determine a safe and tolerable dose of vincristine, when administered with irinotecan
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To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
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Determine the pharmacokinetics of vincristine and irinotecan
時間枠：Length of study
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To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
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Length of study
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Determine the incidence and severity of other toxicities
時間枠：Length of study
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To determine the incidence and severity of other toxicities of this combination.
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Length of study
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Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
時間枠：Length of study
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To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
|
Length of study
|
協力者と研究者
捜査官
- スタディチェア：Sylvain Baruchel, MD、The Hospital for Sick Children
出版物と役立つリンク
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
キーワード
その他の研究ID番号
- P9972
- COG-P9972 (その他の識別子：Children's Oncology Group)
- POG-P9972 (その他の識別子：Pediatric Oncology Group)
- CDR0000068273 (その他の識別子：Clinical Trials.gov)
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。