Clinical Trial Title Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Trial Status Open to Enrollment
Start Date 01/03/2012
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Acute Myeloid Leukemia (AML)
Description This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
Eligibility Criteria Age: <30 years of age at the time of study enrollment

Newly diagnosed with de novo Acute Myelogenous Leukemia (AML)

Patients with previously untreated primary AML who meet the customary criteria for AML with >20% bone marrow blasts

Patients with biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible

Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed

Hydroxyurea and ATRA must be discontinued prior to initiation of protocol therapy

Patients who have previously received any other chemotherapy, radiation therapy, or any other anti-leukemic therapy are not eligible for this study
IRB Number

Study status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone (503) 276-9300
Contact Fax
Contact E-Mail