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Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
This study is currently recruiting patients.
Sponsored by: | Memorial Sloan-Kettering Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy such as arsenic trioxide work in different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
Condition | Treatment or Intervention | Phase |
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accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia |
Drug: arsenic trioxide Drug: imatinib mesylate Procedure: chemotherapy Procedure: enzyme inhibitor therapy Procedure: protein tyrosine kinase inhibitor therapy |
Phase I Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Arsenic Trioxide and Imatinib Mesylate in Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
OBJECTIVES: Primary
OUTLINE: This is a phase I dose-escalation study of arsenic trioxide followed by a phase II study.
NOTE: *For patients who receive a second course of induction therapy
Cohorts of 6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of consolidation therapy, patients may continue imatinib mesylate off study at the discretion of the physician. Patients who become candidates for stem cell transplantation at any time during the study are removed from study.
PROJECTED ACCRUAL: A total of 6-43 patients (6-12 for phase I and 37 [including 6 patients from phase I] for phase II) will be accrued for this study within 2 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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