Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies
Phase 2
Terminated
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT01009931
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TPA + Dexamethasone and CMT 12-O-tetradecanoylphorbol-13-acetate 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) TPA + Dexamethasone and CMT Dexamethasone 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) TPA + Dexamethasone and CMT Choline magnesium trisalicylate 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate)
- Primary Outcome Measures
Name Time Method Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate) 42 months Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25% 43 months
- Secondary Outcome Measures
Name Time Method Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression 48 months Cycle 1 of treatment
Trial Locations
- Locations (1)
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States