FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
A Pilot Study Of FR901228, Or Depsipeptide (NSC #630176) For Adult Patients With Advanced Hematologic Cancers
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome, acute myeloid leukemia, or intermediate-grade or follicular non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).
- Determine the disease response in patients treated with this drug.
- Determine the pharmacokinetic and pharmacodynamic correlates of this drug, including measurement of serum plasma levels, H3 and H4 acetylation, apoptosis induction, differentiation, and multidrug-resistant (MDR) phenotype expression in these patients.
OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
-
-
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:
One of the following diagnoses:
Histologically confirmed refractory or relapsed acute myeloid leukemia (AML)
- Failed anthracycline-based chemotherapy
- Ineligible for or refused allogeneic stem cell transplantation
Elderly patients with newly diagnosed AML
- Ineligible for or refused standard chemotherapy
Histologically confirmed high-risk myelodysplastic syndromes
Eligible subtypes include:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Ineligible for or refused allogeneic bone marrow transplantation
Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL)
- Relapsed after high-dose therapy OR
- Ineligible for allogeneic or autologous stem cell transplantation
- Evaluable lesions by radiologic study or physical examination
Histologically confirmed follicular NHL
- Progressed after anthracycline-based chemotherapy and rituximab
- Evaluable lesions by radiologic study or physical examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome)
- SGOT and SGPT less than 2 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- Cardiac ejection fraction greater than 50%
- No cardiac hypertrophy
- No known conduction heart disease
- No New York Heart Association class III or IV heart disease that would make it difficult to assess patient during study participation
- No significant prior heart disease
- No significant prior secondary or tertiary heart block
- No significant prior atrial or ventricular arrhythmia requiring therapeutic intervention or antiarrhythmics for rate control
Pulmonary
- No severe debilitating pulmonary disease that would make it difficult to assess patient during study participation
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- Potassium ≥ 4.0 mmol/L (supplementation allowed)
- Magnesium ≥ 2.0 mg/dL (supplementation allowed)
- No other concurrent active malignancy except basal cell skin cancer
- No other concurrent significant co-morbidity that would make it difficult to assess patient during study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 2 weeks since prior epoetin alfa or filgrastim (G-CSF)
- At least 4 weeks since prior cytokines
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior systemic chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational agents
No concurrent drugs that may prolong the QTc interval
- FR901228 (depsipeptide) may be administered after a 5-half-life washout period following the use of these drugs
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
捜査官
- スタディチェア:Virginia Klimek, MD、Memorial Sloan Kettering Cancer Center
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)
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
- 再発性グレード 3 濾胞性リンパ腫
- 再発性成人びまん性大細胞型リンパ腫
- 過剰な芽球を伴う難治性貧血
- 形質転換中の過剰な芽球を伴う難治性貧血
- 慢性骨髄単球性白血病
- 以前に治療された骨髄異形成症候群
- 二次性骨髄異形成症候群
- 11q23 (MLL) 異常を伴う成人急性骨髄性白血病
- inv(16)(p13;q22)を伴う成人急性骨髄性白血病
- t(15;17)(q22;q12)を伴う成人急性骨髄性白血病
- t(16;16)(p13;q22)を伴う成人急性骨髄性白血病
- t(8;21)(q22;q22)を伴う成人急性骨髄性白血病
- 再発性成人急性骨髄性白血病
- 未治療の成人急性骨髄性白血病
- 再発性成人びまん性小細胞分裂型リンパ腫
- 再発性成人びまん性混合細胞リンパ腫
- 再発性グレード 1 濾胞性リンパ腫
- 再発性グレード 2 濾胞性リンパ腫
- 骨髄異形成/骨髄増殖性腫瘍、分類不能
- 非定型慢性骨髄性白血病、BCR-ABL1陰性
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000069473
- MSKCC-00116
- NCI-1715
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。