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| Tracking Information | |||||
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| First Received Date ICMJE | July 8, 2002 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | March 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00041379 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia | ||||
| Official Title ICMJE | Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia | ||||
| 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 Waldenstrom's macroglobulinemia. |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Drug: beta alethine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00041379 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000069494, LIFETIME-LTP-01-03 | ||||
| Study Sponsor ICMJE | LifeTime Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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