Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-01

Study Completion Date

2006-04-10

Brief Summary

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The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.

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Detailed Description

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Existing pre-clinical and clinical data suggest that SCH66336, a farnesyl transferase inhibitor,exhibits significant activity against CML cells, and in fact may have synergistic activity in combination with imatinib mesylate. Thus, the objectives to the study are (1) to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of lonafarnib (SCH66336), a farnesyl transferase inhibitor, in combination with imatinib mesylate (Gleevec) in patients with chronic phase, accelerated phase, and blast crisis CML; (2) to assess the pharmacokinetics of the combination of lonafarnib and Gleevec in these patients; and (3) to assess in a preliminary way the biologic activity of the combination of lonafarnib and Gleevec in these patients.

Conditions

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Chronic Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gleevec + SCH 66336

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.

Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.

Group Type EXPERIMENTAL

Lonafarnib (SCH66336)

Intervention Type DRUG

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.

Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.

Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.

Imatinib Mesylate (Gleevec)

Intervention Type DRUG

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day.

Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day.

Interventions

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Lonafarnib (SCH66336)

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.

Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.

Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.

Intervention Type DRUG

Imatinib Mesylate (Gleevec)

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day.

Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day.

Intervention Type DRUG

Other Intervention Names

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SCH66336 Sarasar Gleevec Imatinib ST1571 NSC-716051

Eligibility Criteria

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Inclusion Criteria

3\) Age \>/= 16 years.

4\) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping eith the policies of the hospital. The only acceptable consent form is attached at the end of the protocol.

5\) Performance status \</= 2 by Zubrod scale.

6\) Patients must have adequate hepatic functions (bilirubin \</= 2.0 mg/dl) and renal functions (creatinine \</= 2 mg/dl).