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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


Phase 1
15 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD defined as the dose preceding that at which 2 of 6 patients experience DLT assessed using NCI CTC version 2.0

Outcome Description:

Non-parametric tests will be used to study the relationship between baseline and post-therapy values at different dose levels and times.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Jorge Cortes

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02338

NCT ID:

NCT00006213

Start Date:

April 2000

Completion Date:

Related Keywords:

  • 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
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Promyelocytic, Acute
  • Myelodysplastic Syndromes
  • Preleukemia
  • Anemia, Aplastic

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030