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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

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)


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Judith E. Karp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068576

NCT ID:

NCT00015951

Start Date:

April 2001

Completion Date:

March 2004

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia  30342-1601