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Sponsored by: |
LifeTime Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00007839 |
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 | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: beta alethine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed low grade B-cell lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000068279, LIFETIME-LTP-99-02, LIFETIME-IRB-0300202, NCI-V00-1628 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00007839 |
Health Authority: | United States: Federal Government |
stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma |
noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II small lymphocytic lymphoma noncontiguous stage II marginal zone lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage I marginal zone lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage III marginal zone lymphoma stage IV small lymphocytic lymphoma stage IV marginal zone lymphoma contiguous stage II marginal zone lymphoma contiguous stage II small lymphocytic lymphoma |
Chronic lymphocytic leukemia Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Recurrence Lymphoma, B-Cell |
Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |