Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

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.

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