Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
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Purpose
This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia
| Condition | Intervention | Phase |
|---|---|---|
|
Blastic Phase Chronic Myelogenous Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive |
Biological: bevacizumab Drug: idarubicin Drug: cytarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase |
- Improvement in response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Controlled toxicity rate graded according to NCI Common Toxicity Criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | July 2001 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (bevacizumab, idarubicin, cytarabine)
Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Other Names:
Drug: idarubicin
Given IV
Other Names:
Drug: cytarabine
Given SC
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in patients with blastic phase chronic myelogenous leukemia.
II. Determine the toxicity profile of this regimen in these patients. III. Determine the effect of bevacizumab on angiogenesis in these patients.
OUTLINE:
Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML), defined by 1 of the following:
- At least 30% blasts in peripheral blood and/or bone marrow
- Presence of extramedullary disease
- Performance status - Zubrod 0-2
- At least 8 weeks
- No prior coagulopathies
- Bilirubin no greater than 1.5 mg/dL
- INR less than 2
- PTT no greater than 60 seconds
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No nephrotic syndrome
- No uncontrolled hypertension
- No New York Heart Association class II-IV heart disease
- No prior thrombotic events
- LVEF ≥ 50%
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis
- Prior hydroxyurea allowed
- Prior imatinib mesylate allowed
- At least 10 days since prior anticoagulants
- No concurrent anticoagulants
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023920 History of Changes |
| Other Study ID Numbers: | NCI-2012-02405, ID00-323, N01CM17003, CDR0000068876 |
| Study First Received: | September 13, 2001 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blast Crisis Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Pathologic Processes Antibodies Antibodies, Monoclonal Cytarabine |
Bevacizumab Idarubicin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Antibiotics, Antineoplastic Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013