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| Sponsors and Collaborators: |
Stanford University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022048 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: bevacizumab |
Phase I Phase II |
| MedlinePlus related topics: | Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS) |
| Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to International Prognostic Scoring System risk status (low (low or intermediate-1) vs high (intermediate-2 or high)).
Patients receive bevacizumab IV over 30-90 minutes. Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at weeks 1, 3, 5, 7, and 9.
PROJECTED ACCRUAL: A total of 16-25 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 confirmed myelodysplastic syndrome (MDS)
At least 1 of the following cytopenias:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No other active malignancy except localized squamous cell or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Arizona | |||||
| Arizona Cancer Center at University of Arizona Health Sciences Center | |||||
| Tucson, Arizona, United States, 85724 | |||||
| United States, California | |||||
| Stanford Cancer Center at Stanford University Medical Center | |||||
| Stanford, California, United States, 94305-5750 | |||||
| United States, Texas | |||||
| University of Texas - MD Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030-4009 | |||||
| Stanford University |
| National Cancer Institute (NCI) |
| Study Chair: | Peter L. Greenberg, MD | Stanford University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068778, SUMC-MDA-ID-01152, MDA-ID-01152, NCI-2771 |
| First Received: | August 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022048 |
| Health Authority: | United States: Federal Government |
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