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

NCT01009931 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-11-04

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Rutgers Cancer Institute of New Jersey

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Biosuccess Biotech Co., Ltd.

    collaborator INDUSTRY

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Roger Strair, MD, PhD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-10-31
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009931 on ClinicalTrials.gov