Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041379
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-07-08
Brief Title:
Beta Alethine in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
LifeTime Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstroms Macroglobulinemia
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase III trial to study the effectiveness of beta alethine in treating patients who have Waldenstroms macroglobulinemia
PURPOSE Phase III trial to study the effectiveness of beta alethine in treating patients who have Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Determine the antitumor effects of low-dose beta alethine in patients with Waldenstroms macroglobulinemia
Determine the effects of this drug on anemia performance status and disease symptoms in these patients
Determine the effects of this drug on the immune system of these patients
Determine the safety of this drug in these patients
OUTLINE This is a multicenter study
Patients receive beta alethine subcutaneously on days 1 15 29 43 57 and 71 Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 13-37 patients will be accrued for this study
Determine the antitumor effects of low-dose beta alethine in patients with Waldenstroms macroglobulinemia
Determine the effects of this drug on anemia performance status and disease symptoms in these patients
Determine the effects of this drug on the immune system of these patients
Determine the safety of this drug in these patients
OUTLINE This is a multicenter study
Patients receive beta alethine subcutaneously on days 1 15 29 43 57 and 71 Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 13-37 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LIFETIME-LTP-01-03 | None | None | None |