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

NCT00006213 | Completed Phase 1

• 4 other identifiers: NCI-2012-02338DM99-290U01CA062461CDR0000067887
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (1)

Treatment (BMS-214662)

EXPERIMENTAL

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; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

BMS-214662 DRUG

Given IV

Also known as: farnesyltransferase inhibitor BMS-214662, FTI BMS 214662

Treatment (BMS-214662)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (BMS-214662)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (BMS-214662)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute; Blast Crisis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts

Interventions

7-cyano-2,3,4,5-tetrahydro-1-(1H-imidazol-4-ylmethyl)-3-(phenylmethyl)-4-(2-thienylsulfonyl)-1H-1,4-benzodiazepine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes

Study Officials

• Jorge Cortes

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: December 24, 2003
• Study Start: April 1, 2000
• Primary Completion: October 1, 2002
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)