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Spots Global Cancer Trial Database for Beta Alethine in Treating Patients With Low-Grade Lymphoma

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Trial Identification

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

Conditions

Lymphoma

Interventions

beta alethine

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Victory Over Cancer, Rockville, Maryland, United States

Contact Details

Name: Suzin Mayerson, PhD

Affiliation: LifeTime Pharmaceuticals

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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