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BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
This study has been completed.
Study NCT00006213   Information provided by National Cancer Institute (NCI)
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes

September 11, 2000
July 23, 2008
July 2000
 
 
 
Complete list of historical versions of study NCT00006213 on ClinicalTrials.gov Archive Site
 
 
 
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
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

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.

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.

Phase I
Interventional
Treatment
  • Leukemia
  • Myelodysplastic Syndromes
Drug: BMS-214662
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006213
 
CDR0000067887, MDA-DM-99290, NCI-450
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP