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

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
cytarabine
mitoxantrone hydrochloride
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Blood and Marrow Transplant Group of Georgia
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
October 15, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00015951
Brief Title
Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
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 Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith E. Karp, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1601
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

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

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