ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006213
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006213

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Jorge Cortes, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Syndrome

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers