Conditions: Leukemia
Keywords: Acute Myelogenous Leukemia Relapsed AML Refractory AML
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
This phase II trial is studying the side effects and how well giving tetradecanoylphorbol acetate together with dexamethasone and choline magnesium trisalicylate works in treating patients with relapsed or refractory acute myeloid leukemia.

Detailed description:

Arms:
arm 1: 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate)

Interventions: intervention 1: 12-O-tetradecanoylphorbol-13-acetate intervention 2: Dexamethasone intervention 3: Choline magnesium trisalicylate
Intervention descriptions: intervention 1: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles. intervention 2: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles. intervention 3: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.

Up to 6 cycles.

Protocol document: