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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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Victory Over Cancer

πŸ‡ΊπŸ‡Έ

Rockville, Maryland, United States

Victory Over Cancer
πŸ‡ΊπŸ‡ΈRockville, Maryland, United States

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