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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006213 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: BMS-214662 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086) in Acute Leukemias, Myelodysplastic Syndromes (RAEB and RAEB-T) and Chronic Myeloid Leukemia in Blast Phase |
Study Start Date: | July 2000 |
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of BMS-214662 in patients with acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase. II. Determine any preliminary evidence of antileukemia activity of this drug in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of BMS-214662 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 toxicities.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 10 months.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphocytic leukemia, or high risk myelodysplastic syndrome (refractory anemia with excess blasts (RAEB) or RAEB in transformation) that has: Not responded (no complete remission (CR)) to initial induction chemotherapy OR Recurred after an initial CR of less than 1 year OR Recurred after an initial CR of greater than 1 year and failed to respond to an initial reinduction attempt OR Recurred more than once OR Chronic myeloid leukemia in myeloid blast phase that has: Not received prior therapy for blast phase OR Failed other prior treatments for blast phase Refractory or relapsed acute promyelocytic leukemia allowed provided failed a prior tretinoin containing regimen Not likely to benefit from allogeneic bone marrow transplantation (i.e., 60 years of physiologic age or over or with no histocompatible donor)
PATIENT CHARACTERISTICS: Age: 15 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prolonged QTc interval on EKG Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (unless evidence of rapidly progressive disease) and recovered At least 24 hours since prior hydroxyurea for rapidly proliferative disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000067887, MDA-DM-99290, NCI-450 |
Study First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006213 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
adult acute promyelocytic leukemia (M3) refractory anemia with excess blasts refractory anemia with excess blasts in transformation previously treated myelodysplastic syndromes childhood myelodysplastic syndromes |
Blast Crisis Leukemia, Lymphoid Precancerous Conditions Chronic myelogenous leukemia Refractory anemia Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Preleukemia Anemia, Refractory Leukemia, Promyelocytic, Acute Acute myeloid leukemia, adult Acute myelocytic leukemia Myelodysplastic syndromes |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Anemia Myeloproliferative Disorders Acute myelogenous leukemia Acute promyelocytic leukemia Leukemia, Myeloid Recurrence Leukemia, Myelogenous, Chronic, BCR-ABL Positive Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |