Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes
Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as etanercept may interfere with the growth of the cancer cells. Combining chemotherapy with biological therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide together with etanercept and to see how well it works in treating patients with myelodysplastic syndromes.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the frequency of hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) treated with arsenic trioxide and etanercept.
- Determine the efficacy of this regimen in patients with intermediate-1 or low-risk MDS that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872.
- Correlate results of ex vivo and in vitro studies of phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment response in patients treated with this regimen.
- Determine parameters that are associated with a high probability of disease response in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 of week 1 and then twice weekly on weeks 2-12 during course 1 (twice weekly on weeks 1-12 during course 2). Patients also receive etanercept subcutaneously twice weekly during weeks 1, 2, 5, 6, 9, and 10. Treatment repeats every 12 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 15-32 patients will be accrued for this study within 8-18 months.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98109-1024
- Fred Hutchinson Cancer Research 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:
Diagnosis of myelodysplastic syndromes (MDS) meeting 1 of the following criteria:
- Intermediate-2 or high-risk disease
- Intermediate-1 or low-risk disease that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872
Not eligible for stem cell transplantation for any of the following reasons:
- Suitable bone marrow donor is not available
- Ineligible for a transplantation protocol
- Not willing to undergo transplantation
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 500/mm^3
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No evidence of cardiac arrhythmia
- No evidence of congestive heart failure
- QTc interval ≤ 460 msec
Pulmonary
- No pneumonia
Other
- Potassium > 4.0 mEq/L (supplemental electrolytes allowed)
- Magnesium > 1.8 mg/dL (supplemental electrolytes allowed)
- No history of anaphylactic reaction to arsenic trioxide
- No active severe infection (e.g., septicemia) within the past 2 weeks
- No other severe disease that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior hematopoietic stem cell transplantation
- More than 4 weeks since prior hematopoietic growth factors for MDS
- More than 4 weeks since prior immunomodulatory therapy for MDS
- No concurrent hematopoietic growth factors for MDS
- No other concurrent immunomodulatory therapy for MDS
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 4 weeks since prior cytotoxic therapy for MDS
- More than 4 weeks since prior experimental therapy for MDS
- No other concurrent cytotoxic therapy for MDS
- No other concurrent experimental therapy for MDS
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
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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Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes
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Efficacy of this regimen in patients with intermediate-1 or low-risk MDS that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872
|
|
Correlate results of ex vivo and in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
|
|
Parameters that are associated with a high probability of response
|
協力者と研究者
捜査官
- 主任研究者：Bart L. Scott, MD、Fred Hutchinson Cancer Center
研究記録日
主要日程の研究
研究開始
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
- 1888.00
- FHCRC-1888.00
- CDR0000380742 (レジストリ識別子：PDQ)
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