Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
-
Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.
-
Determine the toxicity and pharmacokinetics of this regimen in these patients.
Secondary
- Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.
OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.
Study Design
Outcome Measures
Primary Outcome Measures
- Efficacy in terms of complete remission rate []
- Toxicity []
- Pharmacokinetics []
Secondary Outcome Measures
- Correlate clinical response to laboratory studies of drug susceptibility []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate
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More than 20% blasts by morphologic criteria
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Relapsed disease ≥ 3 months after prior complete remission
-
Blasts CD33-positive by flow cytometry
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No primary hematologic disorder that preceded initial presentation with AML
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No documented secondary AML related to prior chemotherapy or toxin exposure
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No acute promyelocytic leukemia (FAB M3)
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Not a candidate for transplant therapy
-
No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
- 60 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≤ 30,000/mm^3 (hydroxyurea allowed)
Hepatic
-
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
-
AST or ALT ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 mg/dL
Other
-
HIV negative
-
No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not planning hematopoietic stem cell transplantation immediately after study therapy
Chemotherapy
-
See Disease Characteristics
-
See Hematopoietic
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
-
More than 1 month since prior investigational agents
-
No other concurrent anticancer therapy
-
No administration of any of the following for 24 hours after cyclosporine administration:
-
Diltiazem
-
Verapamil
-
Erythromycin
-
Clarithromycin
-
Metoclopramide
-
Phenytoin
-
Rifampin
-
Phenobarbital
-
Aminoglycosides
-
Amphotericin B
-
Vancomycin
-
Cimetidine
-
Ranitidine
-
Trimethoprim/sulfamethoxazole
-
Ketoconazole
-
Fluconazole
-
Itraconazole
-
Voriconazole
-
Carbamazepine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109-1024 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephen H. Petersdorf, MD, Fred Hutchinson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1820.00
- FHCRC-1820.00
- CDR0000378021