Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes
Phase I Study of CC-5013 (Lenalidomide NSC# 703813) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome
調査の概要
状態
条件
介入・治療
詳細な説明
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of lenalidomide in pediatric patients with relapsed or refractory solid tumors.
II. Determine the toxic effects of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine, preliminarily, the feasibility of administering this drug to pediatric patients with relapsed or refractory myelodysplastic syndromes.
II. Determine, preliminarily, the antitumor activity of this drug in both patient populations.
III. Determine immunologic changes in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (solid tumor vs myelodysplastic syndromes [MDS]).
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients with solid tumors receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients with MDS receive a fixed dose (do not undergo dose escalation) of lenalidomide. After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
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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California
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Arcadia、California、アメリカ、91006-3776
- COG Phase I Consortium
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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:
Diagnosis of 1 of the following:
Histologically confirmed solid tumor
- No brain tumors
Myelodysplastic syndromes (MDS)
- No refractory anemia with excess blasts in transformation or other forms of acute myeloid leukemia (AML)
- No FAB diagnosis of refractory anemia with excess blasts in transition and other forms of AML
- Newly diagnosed MDS with chromosome 5q abnormalities
- Relapsed or refractory disease including relapse after stem cell transplantation
- Measurable or evaluable disease (solid tumor patients only)
- No known curative or life-prolonging therapy exists
- No bone marrow involvement by tumor (solid tumor patients only)
- No CNS tumors
- Performance status - Karnofsky 50-100% (for patients > 10 years of age)
- Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
- Absolute neutrophil count ≥ 1,000/mm^3 (for patients with solid tumors)
Platelet count ≥ 100,000/mm^3 (30,000 for patients with MDS)
- Only patients with MDS may receive transfusions to support platelet counts
- Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 110*
- Albumin ≥ 2 g/dL
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
Creatinine based on age as follows:
- Creatinine ≤ 0.8 mg/dL (for patients ≤ 5 years of age)
- Creatinine ≤ 1 mg/dL (for patients 6 to 10 years of age)
- Creatinine ≤ 1.2 mg/dL (for patients 11 to 15 years of age)
- Creatinine ≤ 1.5 mg/dL (for patients over 15 years of age)
- No parent or sibling with a known history of venous thrombosis before the age of 50 OR arterial thrombosis before the age of 40
- No thromboembolic event except catheter-related thrombosis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- Body surface area ≥ 0.4m^2
- No uncontrolled infection
- No active graft-vs-host disease from prior stem cell transplant or rescue
- Recovered from prior immunotherapy
- At least 1 week since prior biologic agents
- At least 1 week since prior hematologic growth factors (2 weeks for pegfilgrastim)
- At least 3 months since prior stem cell transplant or rescue (without total body irradiation [TBI])
- Prior thalidomide allowed
- No other concurrent immunotherapy
- No other concurrent biologic therapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- Concurrent dexamethasone allowed provided the dose has been either decreasing or stable for the past 7 days
- See Biologic therapy
- Recovered from prior radiotherapy
- At least 2 weeks since prior local palliative (small port) radiotherapy
- At least 6 months since prior TBI, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- No concurrent radiotherapy
- No other concurrent investigational drugs or agents
- No other concurrent anticancer 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
- 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:Treatment (lenalidomide)
Patients receive oral lenalidomide once daily on days 1-21.
Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
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経口投与
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 |
---|---|---|
Maximum tolerated dose of lenolidomide defined as the maximum dose at which fewer than one-third of patients experience DLT
時間枠:28 days
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Graded using the CTCAE version 3.0.
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28 days
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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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Overall response assessed using RECIST criteria
時間枠:Up to 30 days after completion of study treatment
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A patient will be considered to have responded if she or he demonstrates either a bone marrow or cytogenetic response.
Each patient will be classified according to the maximum response of the two criteria, where the classification from maximum to minimum will be: CR, PR or nonresponse.
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Up to 30 days after completion of study treatment
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Adverse events defined using the NCI CTCAE version 3.0
時間枠:Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
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協力者と研究者
捜査官
- 主任研究者:Stacey Berg、COG Phase I Consortium
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
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2012-01820 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
- U01CA097452 (米国 NIH グラント/契約)
- COG-ADVL0319
- NCI-P6553
- CDR0000413700
- NCI-06-C-0052
- ADVL0319 (その他の識別子:CTEP)
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。
レナリドミドの臨床試験
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University of Alabama at BirminghamJanssen Scientific Affairs, LLC; Amgen完了