Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin.
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Determine the overall response rate and duration of response of patients treated with this regimen.
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Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed CD33+ acute myeloid leukemia (AML)
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In first relapse from chemotherapy
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Complete response lasting at least 3 months before relapse
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No CNS leukemia
-
No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia)
PATIENT CHARACTERISTICS:
Age:
- 60 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
-
WBC less than 30,000/mm^3
-
No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation
Hepatic:
-
Bilirubin no greater than 1.5 mg/dL
-
PT and PTT no greater than 1.5 times upper limit of normal OR
-
INR no greater than 1.3
-
No history of chronic hepatitis or cirrhosis
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
-
No uncontrolled congestive heart failure
-
No New York Heart Association class III or IV heart disease
Pulmonary:
- No severe pulmonary disease
Other:
-
HIV negative
-
No other concurrent medical disease that would preclude study entry
-
No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli
-
No other concurrent malignancy
-
No known human anti-human antibodies
-
No uncontrolled seizure disorder
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No active uncontrolled infection
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Not pregnant or nursing
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Negative pregnancy test
-
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
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No prior allogeneic or autologous stem cell transplantation
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No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)
Chemotherapy:
-
See Disease Characteristics
-
At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 2 weeks since prior systemic radiotherapy
Surgery:
-
At least 2 weeks since prior major surgery
-
No prior organ allograft
Other:
-
At least 3 weeks since prior antileukemic therapy and recovered
-
No other concurrent investigational therapy
-
No concurrent immunosuppressive therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genta Incorporated | Berkeley Heights | New Jersey | United States | 07922 |
Sponsors and Collaborators
- Genta Incorporated
Investigators
- Study Chair: Stanley R. Frankel, MD, Genta Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000068721
- GENTA-GA210
- UCCRC-10928