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Sponsored by: |
James P. Wilmot Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258271 |
RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib mesylate may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: cladribine Drug: cytarabine Drug: filgrastim Drug: imatinib mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Leukemias |
Estimated Enrollment: | 18 |
Study Start Date: | March 2005 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral imatinib mesylate once daily on days 1-15 and cladribine IV over 2 hours and cytarabine IV over 4 hours on days 3-7. Patients also receive filgrastim (G-CSF) subcutaneously on days 2-7. Treatment repeats every 15 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) or blastic phase chronic myelogenous leukemia (CML)
Refractory AML defined as any of the following:
Relapsed AML defined as the following:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Other
No concurrent therapeutic anticoagulation with warfarin
United States, New York | |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Camille Abboud, MD 585-275-4099 camille_abboud@urmc.rochester.edu |
Principal Investigator: | Camille Abboud, MD | James P. Wilmot Cancer Center |
Study ID Numbers: | CDR0000448638, URCC-U26403, URCC-RSRB-10427, NOVARTIS-CSTI571AUS161 |
Study First Received: | November 22, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00258271 |
Health Authority: | Unspecified |
recurrent adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult acute megakaryoblastic leukemia (M7) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) |
adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia without maturation (M1) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Cladribine Leukemia, Monocytic, Acute Blast Crisis Chronic myelogenous leukemia Hematologic Diseases Acute myelogenous leukemia Myeloproliferative Disorders Acute myelomonocytic leukemia Leukemia, Myeloid Di Guglielmo's syndrome Leukemia, Myeloid, Acute Recurrence |
Imatinib Leukemia, Myelomonocytic, Acute Leukemia Leukemia, Erythroblastic, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Acute erythroblastic leukemia Acute myeloid leukemia, adult Bone Marrow Diseases Acute monoblastic leukemia Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Cell Transformation, Neoplastic |