Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies
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.
Drug: Choline magnesium trisalicylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) Plus Dexamethasone & Choline Magnesium Trisalicylate in the Treatment of Patients With Relapsed/Refractory Acute Myelogenous Leukemia|
- Response rate > 20% for 12-O-tetradecanoylphorbol-13- acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
- Grade 3 and 4 non-hematologic treatment-related toxicity rates < 25% [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]
- Effects of treatment on immunophenotype, signaling profile, and nuclear NF-kB expression [ Time Frame: 48 months ] [ Designated as safety issue: No ]Cycle 1 of treatment
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: TPA + Dexamethasone and CMT
12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.
Other Name: TPADrug: Dexamethasone
Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Other Name: Dexamethasone sodium phosphateDrug: Choline magnesium trisalicylate
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.
Other Name: Trilisate
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009931
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Roger Strair, MD, PhD||Rutgers Cancer Institute of New Jersey|