Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
A Phase I Dose Escalation and Pharmacokinetic Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available.
The purpose of this study is to find the answers to the following research questions:
- What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days?
- What are the side effects of clofarabine when given on this schedule?
- How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug?
- Will oral clofarabine help treat solid tumor cancer?
調査の概要
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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Texas
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Dallas、Texas、アメリカ、75246
- Mary Crowley Medical Research Center
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Tyler、Texas、アメリカ、75702
- Tyler Cancer Institute
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Washington
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Spokane、Washington、アメリカ、99218
- Cancer Care Northwest
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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:
- Have a pathologically confirmed diagnosis of a solid tumor malignancy that is refractory to conventional therapy or for which no therapy exists. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Be greater than or equal to 18 years old.
- Must not be eligible for therapy of higher curative potential. (NB: Where an alternative therapy has been shown to prolong survival in an analogous population, that therapy will be offered to the patient prior to discussing this study.)
- Have a Karnofsky Performance Status (KPS) of greater than or equal to 70.
- Have an estimated life expectancy of greater than or equal to 12 weeks.
- Be male or a non-pregnant, non-lactating female. Patients who are fertile must agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy.
- Have a negative serum or urine pregnancy test within 10 days of study treatment (if patient is a female of childbearing potential).
- Sign a written informed consent form.
- Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: A. ANC: greater than or equal to 1.5 × 10 ^9th/L; B. Platelets: greater than or equal to 100 × 10 ^9th/L; C.Serum bilirubin: less than 2.0 mg/dL; D. AST and ALT: less than 3 x ULN* without liver involvement OR less than 5 x ULN with liver involvement; E. Serum creatinine: less than or equal to 2.0 mg/dL. NOTE: ULN = Institutional Upper Limit of Normal.
Exclusion Criteria:
- Have received previous treatment with clofarabine.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have received any chemotherapy, major surgery, or irradiation, whether conventional or investigational, 28 days before treatment in this study (42 days for mitomycin-C or nitrosourea).
- Have not recovered from acute toxicities of all previous therapy prior to enrollment.
- Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study (eg, uncontrolled severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, etc). Patients with abnormal cardiac function who are in consideration for study participation should be discussed with the Medical Monitor prior to enrollment.
- Have received prior radiation therapy to greater than or equal to 25% of the bone marrow (eg, no whole pelvic irradiation is allowed) and have not recovered from the acute side effects of radiotherapy.
- Have symptomatic or untreated central nervous system (CNS) metastases.
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:非ランダム化
- 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:1
Single-arm, dose escalation
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Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response.
The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.
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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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To determine the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) and dose limiting toxicity (DLT) of oral clofarabine when administered once daily for 5 days every 28 days to adult patients with locally advanced or metastatic solid tumors
時間枠:Length of Study
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Length of Study
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協力者と研究者
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
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。
固形腫瘍の臨床試験
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AstraZeneca募集Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃がん、乳がん、卵巣がんスペイン, アメリカ, ベルギー, イギリス, フランス, ハンガリー, カナダ, 大韓民国, オーストラリア
clofarabine (oral formulation)の臨床試験
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Biomedical Development CorporationNational Heart, Lung, and Blood Institute (NHLBI); University of Kentuckyわからない
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New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)完了
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Federal University of the Valleys of Jequitinhonha...完了
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University of Wisconsin, MadisonNational Institute on Aging (NIA)募集
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Inje University完了
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University of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)完了
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EMD Serono完了