A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
Data Collection
Hematologic Diseases+3
+ Leukemia
+ Leukemia, Myeloid
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location