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| Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00015951 |
Purpose
RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer.
PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes |
Drug: bevacizumab Drug: cytarabine Drug: mitoxantrone hydrochloride |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Cytarabine Cytarabine hydrochloride Mitoxantrone hydrochloride Mitoxantrone Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of the Recombinant Human Monoclonal Anti-Vascular Endothelial Growth Factor Antibody (rhuMAB VEGF) Bevacizumab (NSC #704865, IND # 7,921) Administered in Times Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxanetrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs) |
| Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cytarabine IV continuously over 72 hours on days 1-3, mitoxantrone IV over 30-60 minutes on day 4, and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-45 patients will be accrued for this study within 1-3 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed poor-risk hematologic malignancy
Relapsed or refractory acute myelogenous leukemia (AML)
Relapsed or refractory MDS
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| United States, Georgia | |||||
| Blood and Marrow Transplant Group of Georgia | |||||
| Atlanta, Georgia, United States, 30342-1601 | |||||
| United States, Maryland | |||||
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
| Baltimore, Maryland, United States, 21231-2410 | |||||
| University of Maryland Greenebaum Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068576, MSGCC-0076, NCI-2490 |
| First Received: | May 6, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00015951 |
| Health Authority: | United States: Federal Government |
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