Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.
調査の概要
詳細な説明
OBJECTIVES: I. Determine the feasibility and toxicity of timed sequential remission induction and consolidation in children with newly diagnosed acute myeloid leukemia. II. Determine the feasibility and toxicity of a single high dose of melphalan with peripheral blood stem cell rescue following an intense timed sequential induction and consolidation in these children.
OUTLINE: This is a multicenter study. Remission induction: Patients receive daunorubicin IV over 15 minutes on days 1-3, cytarabine IV continuously on days 1-7, oral thioguanine daily on days 1-7, and cytarabine intrathecally (IT) on day 1. Cytarabine IV over 3 hours is administered every 12 hours on days 10-12. Filgrastim (G-CSF) is administered IV or subcutaneously (SQ) beginning on day 13 and continuing until blood counts recover. On approximately day 28, patients undergo a bone marrow aspirate and biopsy to assess response. Patients who have attained an M1 or M2a status proceed to consolidation or, if a 5/5 or 6/6 HLA matched sibling donor is available, proceed to allogeneic bone marrow transplantation. Patients with greater than 25% blasts go off study. Consolidation 1: Patients receive daunorubicin IV over 15 minutes on days 1 and 2, cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, and asparaginase on days 2 and 9. G-CSF IV or SQ begins on day 10 and continues until blood counts recover. Consolidation 2: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. G-CSF IV or SQ begins on day 6 and continues until blood counts recover. Peripheral blood stem cells (PBSC) are collected after the second course of consolidation. Consolidation 3: Treatment is repeated as in consolidation 1. Patients who remain in morphologic remission after consolidation 3 proceed with therapy. Patients receive melphalan IV over 30 minutes on day -2, then PBSC are reinfused on day 0. G-CSF IV or SQ begins on day 1 and continues until blood counts recover. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 8 months.
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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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Tucson、Arizona、アメリカ、85724
- Arizona Cancer Center
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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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Palo Alto、California、アメリカ、94304
- Lucile Packard Children's Hospital at Stanford
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San Diego、California、アメリカ、92123-4282
- Children's Hospital and Health Center
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Florida
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Jacksonville、Florida、アメリカ、32207
- Nemours Children's Clinic
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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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Maine
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Scarborough、Maine、アメリカ、04074
- Maine Children's Cancer Program
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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、02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit、Michigan、アメリカ、48201
- Children's Hospital of Michigan
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Missouri
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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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Hackensack、New Jersey、アメリカ、07601
- Tomorrows Children's Institute
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New York
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New York、New York、アメリカ、10029
- Mount Sinai School of Medicine
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Texas
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Dallas、Texas、アメリカ、75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth、Texas、アメリカ、76104
- Cook Children's Medical Center - Fort Worth
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Midwest Children's Cancer Center
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Quebec
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Montreal、Quebec、カナダ、H3H 1P3
- Montreal Children's Hospital
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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, previously untreated primary acute myeloid leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down syndrome
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram Pulmonary: No uncontrolled, life threatening pneumonia Other: No uncontrolled, life threatening sepsis or meningitis Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy
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：Chemo + STEM cell
See detailed description.
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他の名前：
他の名前：
他の名前：
他の名前：
他の名前：
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy
時間枠：Length of study
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To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML.
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Length of study
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Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue
時間枠：Length of study
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To test the feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue following an intense timed-sequential induction and consolidation.
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Length of study
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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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Make observations regarding PCR evidence of Minimal Residual Disease
時間枠：Length of study
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To make observations regarding PCR evidence of Minimal Residual Disease in patients with relevant specific translocations who obtain a clinical remission.
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Length of study
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協力者と研究者
捜査官
- スタディチェア：Craig A. Hurwitz, MD、Maine Children's Cancer Program at Barbara Bush Children's Hospital
出版物と役立つリンク
一般刊行物
- Hurwitz CA, Chang M, Graham M, et al.: Timed-sequential remission induction and intensification followed by stem cell rescue for childhood AML -a POG pilot study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1553, 2002.
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
追加の関連 MeSH 用語
その他の研究ID番号
- 9822
- POG-9822
- CDR0000067253
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