Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2005-05-01
• 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 high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine; Gemtuzumab

Criteria

DISEASE CHARACTERISTICS:

• One of the following diagnoses:

• Primary refractory acute myeloid leukemia (AML)

• More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy

• No prior remission

• Relapsed AML

• More than 10% blasts in the bone marrow or blood after documented remission

• Prior remission lasted more than 30 days

• No prior treatment for current relapse

• CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients

• No active CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 17 and over

Performance status:

• 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

• WBC less than 30,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

• No veno-occlusive disease of the liver

• No chronic liver disease unless due to AML

Renal:

• Not specified

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active serious infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 6 months since prior stem cell transplantation

Chemotherapy:

• See Disease Characteristics

• Prior etoposide and/or thioguanine during remission induction allowed

• Prior hydroxyurea for control of AML allowed

• At least 24 hours since prior hydroxyurea

• At least 3 months since prior high-dose cytarabine (greater than 2 g/m^2/dose)-containing regimen

• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed

• Concurrent ophthalmic corticosteroids allowed

• Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• More than 2 months since prior cytotoxic therapy