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Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Myelodysplastic Syndromes

Intervention: bevacizumab (Biological); cytarabine (Drug); mitoxantrone hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Judith E. Karp, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center

Summary

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.

Clinical Details

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 Mitoxantrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs)

Study design: Primary Purpose: Treatment

Detailed description: OBJECTIVES:

- Determine the clinical effectiveness of bevacizumab, cytarabine, and mitoxantrone in

patients with poor-risk hematologic malignancies.

- Determine the toxic effects of this regimen in these patients.

- Determine whether this regimen can induce cell apoptosis in these patients.

- Determine the effects of bevacizumab on coagulation profiles in these patients.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed poor-risk hematologic malignancy

- Relapsed or refractory acute myelogenous leukemia (AML)

- Primary induction failure

- Myelodysplasia(MDS)-related AML

- Secondary AML

- Relapsed or refractory MDS

- Primary induction failure

- Refractory anemia with excess blasts (RAEB)

- RAEB in transformation

- Chronic myelomonocytic leukemia

- Chronic myelogenous leukemia in blast crisis

- Failure of prior primary induction therapy or relapse after achieving complete

remission allowed only if no more than 3 courses of prior induction/reinduction therapy were received

- No hyperleukocytosis (50,000 or more leukemic blasts/mm3)

- No active CNS leukemia

PATIENT CHARACTERISTICS: Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- No disseminated intravascular coagulation

Hepatic:

- AST/ALT no greater than 2 times normal

- Alkaline phosphatase no greater than 2 times normal

- Bilirubin no greater than 1. 5 times normal

Renal:

- Creatinine no greater than 1. 5 times normal

Cardiovascular:

- LVEF at least 45% by MUGA or echocardiogram

- No myocardial infarction within the past 3 months

- No history of severe coronary artery disease

- No cardiomyopathy

- No New York Heart Association class III or IV heart disease (congestive heart

failure) Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active uncontrolled infection

- No history of cytarabine-related neurotoxicity

- No evidence of graft-versus-host disease

PRIOR CONCURRENT THERAPY: Biologic therapy:

- At least 1 week since prior hematopoietic growth factors including epoetin alfa,

filgrastim (G-CSF), and sargramostim (GM-CSF)

- At least 1 week since prior interleukin-3 or interleukin-11

- At least 4 weeks since prior autologous stem cell transplantation

- At least 90 days since prior allogeneic stem cell transplantation

- No other concurrent immunotherapy

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy and recovered

- No prior cytarabine administered as a 72-hour continuous infusion followed by

mitoxantrone IV over 30 minutes

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- At least 2 weeks since prior immunosuppressive therapy

- No other concurrent investigational or commercially available antitumor therapy

Locations and Contacts

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia 30342-1601, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2001
Last updated: September 23, 2009

Page last updated: August 23, 2015

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