Beta Alethine in Treating Patients With Low-Grade Lymphoma
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|ClinicalTrials.gov Identifier: NCT00007839|
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 8, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: beta alethine||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007839
|United States, Maryland|
|Victory Over Cancer|
|Rockville, Maryland, United States, 20852|
|Study Chair:||Suzin Mayerson, PhD||LifeTime Pharmaceuticals|