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

NCT ID: NCT00015951

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2004-03-31

Brief 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.

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Study Design

• Primary Study Purpose: TREATMENT

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

cytarabine

Intervention Type: DRUG

mitoxantrone hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Maryland Greenebaum Cancer Center

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

UM Greenebaum Cancer Center

Principal Investigators

Judith E. Karp, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

MSGCC-0076

Identifier Type: -

Identifier Source: secondary_id

NCI-2490

Identifier Type: -

Identifier Source: secondary_id

CDR0000068576

Identifier Type: -

Identifier Source: org_study_id