Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007839
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-01-06
Brief Title:
Beta Alethine in Treating Patients With Low-Grade Lymphoma
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 B-Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2010-04
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 low-grade lymphoma
PURPOSE Phase III trial to study the effectiveness of beta alethine in treating patients who have low-grade lymphoma
Detailed Description:
OBJECTIVES
Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma
Assess the effects of this regimen on delayed-type hypersensitivity in these patients
Assess the safety of this regimen in this patient population
OUTLINE This is an multicenter study
Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6 doses in the absence of unacceptable toxicity Patients with no evidence of tumor progression may receive additional courses of therapy
Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they withdraw due to an adverse event
PROJECTED ACCRUAL Approximately 13-37 patients will be accrued for this study
Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma
Assess the effects of this regimen on delayed-type hypersensitivity in these patients
Assess the safety of this regimen in this patient population
OUTLINE This is an multicenter study
Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6 doses in the absence of unacceptable toxicity Patients with no evidence of tumor progression may receive additional courses of therapy
Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they withdraw due to an adverse event
PROJECTED ACCRUAL Approximately 13-37 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 |
|---|---|---|---|
| NCI-V00-1628 | None | None | None |
| LIFETIME-LTP-99-02 | None | None | None |
| LIFETIME-IRB-0300202 | None | None | None |