Beta Alethine in Treating Patients With Low-Grade Lymphoma

Phase 1

• Conditions: Lymphoma

• Registration Number: NCT00007839
• Lead Sponsor: LifeTime Pharmaceuticals

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 I/II 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.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2001-01-06
• Study First Submitted QC: 2003-10-07
• Study First Posted: 2003-10-08
• Status Verified: 2010-04
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Victory Over Cancer; 🇺🇸 Rockville, Maryland, United States