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BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00006213
Recruitment Status : Completed
First Posted : December 24, 2003
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. 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 or disease Intervention/treatment Phase
Adult Acute Promyelocytic Leukemia (M3) Blastic Phase Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Refractory Anemia With Excess Blasts Refractory Anemia With Excess Blasts in Transformation Relapsing Chronic Myelogenous Leukemia Drug: BMS-214662 Other: pharmacological study Other: laboratory biomarker analysis Phase 1

Detailed Description:

PRIMARY 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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 : April 2000
Primary Completion Date : October 2002


Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment (BMS-214662)
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.
Drug: BMS-214662
Given IV
Other Names:
  • farnesyltransferase inhibitor BMS-214662
  • FTI BMS 214662
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies


Outcome Measures

Primary Outcome Measures :
  1. MTD defined as the dose preceding that at which 2 of 6 patients experience DLT assessed using NCI CTC version 2.0 [ Time Frame: 4 weeks ]
    Non-parametric tests will be used to study the relationship between baseline and post-therapy values at different dose levels and times.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have:

    • AML, ALL, or high-risk MDS (RAEB or RAEB-t) that has:

      • Not responded (no CR) to initial induction chemotherapy, or
      • Recurred after an initial CR of < 1 year, or
      • Recurred after an initial CR of > 1 year and failed to respond to an initial reinduction attempt, or
      • Recurred more than once, or
    • Chronic myeloid leukemia in myeloid blast phase

      • Patients with CML blast phase may receive BMS-214662 as their first therapy for blast phase or after failing other treatments for blast phase
    • Patients with refractory or relapsed acute promyelocytic leukemia are eligible provided they have failed an ATRA-containing regimen
  • Performance status of =< 0-2
  • Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital
  • Patients must have been off chemotherapy for the 4 weeks prior to entering this study and recovered from the toxic effects of that therapy; patients with evidence of rapidly progressive disease (i.e., absolute peripheral blood blast count >= 5 x 10^9/L and increasing by >= 1 x 10^9/L/24 hours) may receive treatment before 4 weeks from the previous treatment providing they have recovered from all toxic effects of that therapy; use of hydroxyurea on patients with rapidly proliferative disease is allowed up to 24 hours prior to the start of therapy
  • Bilirubin =< 1.5 mg/dL
  • Creatinine =< 1.5 mg/dL or creatinine clearance >= 60 mL/hr
  • Patients who are likely to benefit from allogeneic bone marrow transplantation (i.e., age < 60 years of physiological age with histocompatible donor) should be excluded from this study unless such therapy is not feasible

Exclusion Criteria:

  • Pregnant and nursing females will be excluded; patients of childbearing potential should practice effective methods of contraception
  • Patients with prolonged QTc interval on EKG are excluded
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006213


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jorge Cortes M.D. Anderson Cancer Center
More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006213     History of Changes
Other Study ID Numbers: NCI-2012-02338
DM99-290
U01CA062461 ( U.S. NIH Grant/Contract )
CDR0000067887 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 24, 2003    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Anemia
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Anemia, Refractory
Blast Crisis
Anemia, Refractory, with Excess of Blasts
Leukemia, Promyelocytic, Acute
Anemia, Aplastic
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes