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

NCT00015951 | Completed Phase 2

• 3 other identifiers: CDR0000068576MSGCC-0076NCI-2490
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

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

Interventions

bevacizumab BIOLOGICAL

cytarabine DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator
• University of Maryland Greenebaum Cancer Center: collaborator

Study Sites (3)

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342-1601, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Blast Crisis; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic

Interventions

Bevacizumab; Cytarabine; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Refractory; Anemia; Myelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Study Officials

• Judith E. Karp, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: March 1, 2004
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

US (3)