Leukemia Clinical Trial
Official title:
A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy in terms of complete remission rate | No | ||
Primary | Toxicity | Yes | ||
Primary | Pharmacokinetics | No | ||
Secondary | Correlate clinical response to laboratory studies of drug susceptibility | No |
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