Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
Recruitment status was Active, not recruiting
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.
Multiple Myeloma and Plasma Cell Neoplasm
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||December 2002|
- 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.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Hillard M. Lazarus, MD||Case Comprehensive Cancer Center|