S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2010-10-01
• 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. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine; Gemtuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute myeloid leukemia (AML)

• FAB M1-2 or M4-7

• No blastic transformation of chronic myelogenous leukemia

• In first relapse after prior complete response

• Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible

• CD33 positive

• Prior myelodysplastic syndromes or secondary AML allowed

• Concurrent enrollment on SWOG-9007 (cytogenetics protocol)

• No clinical or documented CNS involvement with AML

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC no greater than 30,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST or ALT no greater than 1.5 times ULN

Renal

• Not specified

Cardiovascular

• No unstable cardiac arrhythmias

• No unstable angina

Other

• HIV negative

• No other malignancy within the past 5 years except for the following:

• Adequately treated basal cell or squamous cell skin cancer

• Carcinoma in situ of the cervix

• Adequately treated stage I or II cancer currently in complete remission

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• No prior gemtuzumab ozogamicin for AML

Chemotherapy

• Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 4 weeks since prior investigational agents and recovered