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Brief Title: Beta Alethine in Treating Patients With Low-Grade Lymphoma
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 ID: NCT00007839
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Victory Over Cancer, Rockville, Maryland, United States
Name: Suzin Mayerson, PhD
Affiliation: LifeTime Pharmaceuticals
Role: STUDY_CHAIR