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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00015951 |
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 |
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Leukemia Myelodysplastic Syndromes |
Biological: bevacizumab Drug: cytarabine Drug: mitoxantrone hydrochloride |
Phase II |
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.
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:
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 |
Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068576, MSGCC-0076, NCI-2490 |
Study First Received: | May 6, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00015951 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
chronic myelomonocytic leukemia secondary acute myeloid leukemia previously treated myelodysplastic syndromes childhood myelodysplastic syndromes |
Antimetabolites Anti-Infective Agents Blast Crisis Chronic Myelomonocytic Leukemia Immunologic Factors Hematologic Neoplasms Precancerous Conditions Bevacizumab Leukemia, Myeloid, Acute Refractory Anemia Leukemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult |
Neoplasm Metastasis Mitogens Analgesics Cytarabine Immunoglobulins Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Anemia Leukemia, Myeloid Endothelial Growth Factors Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Recurrence |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome |
Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Analgesics Cytarabine Disease Neoplasms by Histologic Type Hematologic Diseases Growth Substances Myelodysplastic Syndromes Leukemia, Myeloid Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |