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

Primary Purpose

Adult Acute Promyelocytic Leukemia (M3), Blastic Phase Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-214662
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Promyelocytic Leukemia (M3)

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (BMS-214662)

Arm Description

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.

Outcomes

Primary Outcome Measures

MTD defined as the dose preceding that at which 2 of 6 patients experience DLT assessed using NCI CTC version 2.0
Non-parametric tests will be used to study the relationship between baseline and post-therapy values at different dose levels and times.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006213
Brief Title
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (BMS-214662)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BMS-214662
Other Intervention Name(s)
farnesyltransferase inhibitor BMS-214662, FTI BMS 214662
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
MTD defined as the dose preceding that at which 2 of 6 patients experience DLT assessed using NCI CTC version 2.0
Description
Non-parametric tests will be used to study the relationship between baseline and post-therapy values at different dose levels and times.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cortes
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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