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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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 |
Leukemia Myelodysplastic Syndromes |
Drug: BMS-214662 |
Phase I |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
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 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000067887, MDA-DM-99290, NCI-450 |
First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006213 |
Health Authority: | United States: Federal Government |
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