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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00016094 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bevacizumab (rhuMAb VEGF) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma |
| Enrollment: | 52 |
| Study Start Date: | April 2001 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bevacizumab
10 mg/kg on day 1 of every 14-day cycle, until progression.
|
Biological: bevacizumab
10 mg/kg
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
Relapsed disease (first or second relapse) after 1 or 2 prior chemotherapy regimens (including investigational agents and/or other antibody therapies) for lymphoma
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
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00016094 History of Changes |
| Other Study ID Numbers: | CDR0000068594, U10CA032102, S0108 |
| Study First Received: | May 6, 2001 |
| Last Updated: | January 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult diffuse large cell lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma anaplastic large cell lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |