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| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2001 | ||||
| Last Updated Date | April 21, 2009 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00016094 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma | ||||
| Official Title ICMJE | Bevacizumab (rhuMAb VEGF) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma | ||||
| Brief Summary | RATIONALE: Monoclonal antibodies such as bevacizumab may stop the growth of cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for non-Hodgkin's lymphoma PURPOSE: Phase II trial to study the effectiveness of bevacizumab in treating patients who have non-Hodgkin's lymphoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Biological: bevacizumab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Stopeck AT, Unger JM, Rimsza LM, Bellamy WT, Iannone M, Persky DO, Leblanc M, Fisher RI, Miller TP. A phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin lymphoma: Southwest oncology group study S0108. Leuk Lymphoma. 2009 Apr 15;:1-8 [Epub ahead of print] | ||||
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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 | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| 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 | NCT00016094 | ||||
| Responsible Party | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office | ||||
| Study ID Numbers ICMJE | CDR0000068594, SWOG-S0108 | ||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2009 | ||||
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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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