R115777 in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia

Phase 1

Completed

• Conditions: Leukemia

• Registration Number: NCT00004009
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have refractory or recurrent acute leukemia or chronic myelogenous leukemia.

Detailed Description

OBJECTIVES: I. Determine toxicities and pharmacokinetics of oral R115777 in adults with refractory acute leukemia or accelerated or blastic phase chronic myelogenous leukemia. II. Determine the effect of R115777 on farnesylation within leukemia cells. III. Determine any clinical response (at least 50% decrease in circulating leukemia cells) to R115777 by these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive oral R115777 for 7-21 days. Patients who achieve complete response (CR) or partial response (PR) following 1-4 courses of treatment may receive up to 4 additional courses. Patients with stable disease may receive another 7-21 day course. If CR or PR is then achieved, patients may receive up to 4 additional courses. Cohorts of 6-12 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which between 17% and 33% of patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-04
• Study Completion: 2001-04
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

University of Iowa College of Medicine; 🇺🇸 Iowa City, Iowa, United States

University of Rochester Cancer Center; 🇺🇸 Rochester, New York, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States