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| Sponsor: | LifeTime Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041379 |
Purpose
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 Waldenstrom's macroglobulinemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: beta alethine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia |
| Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive beta alethine subcutaneously on days 1, 15, 29, 43, 57, and 71. Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of Waldenstrom's macroglobulinemia
Positive delayed-type hypersensitivity (DTH) response
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00041379 History of Changes |
| Other Study ID Numbers: | CDR0000069494, LIFETIME-LTP-01-03 |
| Study First Received: | July 8, 2002 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
Waldenstrom macroglobulinemia |
|
Lymphoma Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Cysteamine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |