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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins; Gemtuzumab

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