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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: National Cancer Institute (NCI); University of Maryland Greenebaum Cancer Center
• Treatments: Bevacizumab; Cytarabine; Endothelial Growth Factors; Mitoxantrone

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