Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the side effects and best dose of bortezomib when given together with daunorubicin and cytarabine and to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• Unequivocally histologically confirmed acute myeloid leukemia (AML)

• At least 20% blasts in the bone marrow based on WHO criteria

• No acute promyelocytic leukemia (M3)

• Antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder

• Concurrent enrollment on CALGB-8461 required

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No ataxia, cranial neuropathy, or peripheral neuropathy >= grade 2

• LVEF >= 40% by ECHO or MUGA scan

• No signs or symptoms of congestive heart failure

• DLCO >= 50% (corrected for hemoglobin)

• No prior therapy for leukemia or pre-leukemic disorders, except for the following:

• emergency leukapheresis;

• emergency treatment for hyperleukocytosis with hydroxyurea;

• cranial radiotherapy for CNS leukostasis (one dose only);

• growth factor/cytokine support

• No other concurrent chemotherapy, except for the following:

• I) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock;

• II) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)

• No concurrent palliative radiotherapy