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

Fred Hutchinson Cancer Center

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Leukemia

Interventions

cyclosporineDRUG

gemtuzumab ozogamicinDRUG

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Efficacy in terms of complete remission rate

Toxicity

Pharmacokinetics

Secondary Outcomes

Correlate clinical response to laboratory studies of drug susceptibility

Data from ClinicalTrials.gov

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