Beta Alethine in Treating Patients With Low-Grade Lymphoma
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma|
|Study Start Date:||August 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007839
|United States, Maryland|
|Victory Over Cancer|
|Rockville, Maryland, United States, 20852|
|Study Chair:||Suzin Mayerson, PhD||LifeTime Pharmaceuticals|