Status:
COMPLETED
Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 ...
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 t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate
- More than 20% blasts by morphologic criteria
- Relapsed disease ≥ 3 months after prior complete remission
- Blasts CD33-positive by flow cytometry
- No primary hematologic disorder that preceded initial presentation with AML
- No documented secondary AML related to prior chemotherapy or toxin exposure
- No acute promyelocytic leukemia (FAB M3)
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00089050
Start Date
May 1 2004
End Date
March 1 2006
Last Update
November 30 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024