NCT00007839

Beta Alethine in Treating Patients With Low-Grade Lymphoma

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: LifeTime Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	beta alethine

Timeline

• Start date: 2000-08-01
• First posted: 2003-10-08
• Last updated: 2013-12-18

Locations

1 site across 1 country: United States