Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Status: Recruiting
Phase: Phase 2
Diagnosis: Leukemia/MDS
NCT ID: NCT01253070
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:
This phase II clinical trial is studying the side effects and how well giving sorafenib tosylate together with chemotherapy works in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin hydrochloride 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 sorafenib tosylate together with combination chemotherapy may kill more cancer cells
Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Amir Fathi, M.D.,
Massachusetts General Hospital
Site-responsible Investigators:
Gabriela Motyckova, MD, PhD,
Dana Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML)
- FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference
Laboratory, per CALGB 20202
- No prior chemotherapy for AML with the following exceptions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiotherapy for CNS leukostasis (one dose only)
- Growth factor and/or cytokine support
- All-trans retinoic acid (ATRA)
- AML patients with an antecedent hematologic disorder allowed provided they did not
receive chemotherapy, including lenalidomide, azacitidine, or decitabine
- Patients with therapy-related AML allowed provided no further exposure to
chemotherapy or radiotherapy for > 3 years, and the primary malignancy is in
remission
- None of the following:
- Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA
- Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1
- Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16(p13.1;q22); CBFBMYH11
- Must be registered on protocols CALGB-8461 and CALGB-20202
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent chemotherapy or radiotherapy