Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060203
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2003-05-06
Brief Title:
Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III 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 III trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma
PURPOSE Phase III 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHARMACIA-196-ONC-0100-006 | None | None | None |
| CWRU-PHAR-1A02 | None | None | None |