Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT00060203
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2003-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: