NCT00060203

Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma

A Phase I/II Study of the Safety and Efficacy of Brostallicin (PNU-166196A) in Adult Patients With Multiple Myeloma That Has Progressed on Prior Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.

Detailed description

OBJECTIVES: * Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma. * Determine the maximum tolerated dose of this drug in these patients. * Determine the time to and duration of response, time to treatment failure, time to tumor progression, and survival in patients treated with this drug. * Determine the safety and tolerability of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Correlate baseline whole blood levels and activity of glutathione with clinical outcome in patients treated with this drug. OUTLINE: This is an open-label, multicenter, dose-escalation study. * Phase I: Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. * Phase II: Additional patients are accrued and treated at the MTD of brostallicin as in phase I. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-52 patients will be accrued for this study.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	brostallicin	Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-03-01
• Completion: 2004-04-01
• First posted: 2003-05-07
• Last updated: 2014-01-16

Locations

1 site across 1 country: United States