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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00372619 |
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: clofarabine Drug: cytarabine Drug: methotrexate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73, 789) in Combination With Cytarabine in Pediatric Patients With Refractory/Relapsed Leukemia |
Estimated Enrollment: | 87 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of clofarabine followed by a phase II study. Patients are stratified according to disease (acute lymphoblastic leukemia [ALL] vs acute myeloid leukemia [AML]).
Induction therapy:
During the first course of induction therapy, cohorts of 10 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.
After the second course of induction therapy, patients with M2 or M3 bone marrow are removed from the study. Patients with M1 bone marrow proceed to maintenance therapy 14-42 days after day 1 of course 2 of induction therapy.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)
Disease must have relapsed after or be refractory to prior induction therapy
AML patients must be in first relapse OR refractory to induction therapy with ≤ 1 attempt at remission induction
ALL patients must be in second or third relapse (no more than 3 prior induction regimens) OR refractory to reinduction in first relapse
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No more than 1 prior autologous or allogeneic hematopoietic stem cell transplantation
Study Chair: | Bassem I. Razzouk, MD | St. Vincent Indianapolis Hospital |
Investigator: | Todd Cooper, DO | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Study ID Numbers: | CDR0000494654, COG-AAML0523 |
Study First Received: | September 6, 2006 |
Last Updated: | December 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00372619 |
Health Authority: | Unspecified |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia |
Clofarabine Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence |
Folic Acid Leukemia Lymphatic Diseases Methotrexate Lymphoproliferative Disorders Lymphoma Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |