Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies
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|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: TPA
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 phosphate
Drug: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|