NCT01009931

Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	12-O-tetradecanoylphorbol-13-acetate	The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.
DRUG	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.
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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-10-01
• Completion: 2014-09-01
• First posted: 2009-11-09
• Last updated: 2015-11-04
• Results posted: 2015-06-22

Locations

1 site across 1 country: United States