Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT01009931|
Recruitment Status : Terminated (Study was terminated early due to lack of experimental medication (supply issues))
First Posted : November 9, 2009
Results First Posted : June 22, 2015
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: 12-O-tetradecanoylphorbol-13-acetate Drug: Dexamethasone Drug: Choline magnesium trisalicylate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||September 2014|
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
- Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate) [ Time Frame: 42 months ]
- Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25% [ Time Frame: 43 months ]
- Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression [ Time Frame: 48 months ]Cycle 1 of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|