Conditions: Leukemia
Keywords: Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.

Detailed description:
OBJECTIVES:

Primary

* To determine the antitumor activity of panobinostat, in terms of objective response rate, time to progression, and survival, in patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.
* To assess the toxicity of panobinostat in these patients.

Secondary

* To perform correlative laboratory studies to assess changes in various proteins that may be altered by histone deacetylase inhibition therapy.

OUTLINE: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo peripheral blood and bone marrow sample collection at baseline and on day 28 of course 1 for correlative laboratory studies. Samples are analyzed by RT-PCR for reactivation of FANCG, FOXO3A, GADD45A, GADD45B, GADD45G, H2AX, and TP73.

After completion of study treatment, patients are followed for at least 4 weeks.

PROJECTED ACCRUAL: A total of 74 patients (37 with acute myeloid leukemia and 37 with acute lymphoblastic leukemia) will be accrued for this study.

Arms:
arm 1: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle

Interventions: intervention 1: panobinostat intervention 2: gene expression analysis intervention 3: reverse transcriptase-polymerase chain reaction intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle intervention 2: Day 1 and day 28 samples intervention 3: Day 1 and day 28 samples intervention 4: Day 1 and day 28 samples

Protocol document: