Clofarabine in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125840
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : February 5, 2014
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Brief Summary:

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 research study of clofarabine will be used for advanced cancer in persons in which 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:

  1. What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days?
  2. What are the side effects of clofarabine when given on this schedule?
  3. How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle.
  4. Will clofarabine help treat a specific cancer?

Condition or disease Intervention/treatment Phase
Solid Tumors Leukemia, Lymphocytic, Acute, Pediatric Leukemia, Lymphocytic, Acute, Adult Leukemia, Myelocytic, Acute, Pediatric Leukemia, Myelocytic, Acute, Adult Myelodysplastic Syndromes, Adult Drug: clofarabine (IV formulation) Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors
Study Start Date : August 2002
Actual Study Completion Date : August 2007

Primary Outcome Measures :
  1. The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a pathologic diagnosis of advanced solid tumors
  • After MTD is established, patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Be greater than or equal to 18 years old
  • Not eligible for therapy of higher curative potential
  • Have a Karnofsky Performance Status (KPS) greater than or equal to 70
  • Have an estimated life expectancy of greater than or equal to 12 weeks
  • Have a negative serum or urine pregnancy test within 7 days of study enrollment (if patient is a female of childbearing potential)
  • Male and female patients who are fertile must agree to use an effective barrier method of birth control (latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy
  • Sign a written informed consent form
  • Able to comply with study procedures and follow-up examinations
  • Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: ANC: greater than or equal to 1.5 × 10 9th/L; Platelets: greater than or equal to 100 × 10 9th/L; Serum bilirubin: less than 2.0 mg/dL; AST and ALT: less than 3 x ULN (Institutional Upper Limit of Normal) without liver involvement OR less than 5 x ULN(*) with liver involvement; Serum creatinine: less than 2.0 mg/dL; Echocardiogram shortening fraction: greater than or equal to 28%(Not on pharmacologic support); or Ejection fraction greater than or equal to 50% (Not on pharmacologic support).

Exclusion Criteria:

  • Received previous treatment with clofarabine.
  • Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
  • Prior malignancy with less than a 2-year disease-free interval, except for adequately treated basal cell or squamous cell skin cancer; or in situ cancer of the cervix.
  • 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, < 4 weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea) and/or 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.).
  • 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 received prior radiation therapy to the mediastinal region.
  • Have a broncho-alveolar pattern evident on chest x-ray.
  • Have symptomatic or untreated central nervous system (CNS) metastases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00125840

United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
US Oncology Tyler Cancer Center
Tyler, Texas, United States, 75702
Sponsors and Collaborators
Genzyme, a Sanofi Company

Additional Information: Identifier: NCT00125840     History of Changes
Other Study ID Numbers: CLO151
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Sanofi:
Pediatric ALL and AML
Adult ALL and AML and MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Leukemia, Lymphoid
Leukemia, Myeloid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents