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

November 2, 2015 updated by: Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Must have a histologically documented relapsed/refractory AML for which there is no standard therapy that has been demonstrated to have curative or palliative potential.
  • ECOG performance status of 0-2.
  • Must be 18 years or older.
  • Estimated life expectancy > 1 month.

  • Laboratory data:

    • total bilirubin ≤ 1.5 x upper limit of normal unless due to Gilbert's syndrome
    • serum creatinine ≤ 2.0 mg/dl
    • AST ≤ 3.0 x upper limit of normal
    • Cardiac ejection fraction > 40%
    • FEV1.0 > 50% predicted
  • Prior therapy: > 3 weeks since chemotherapy, biological therapy or radiation; anticipated maximum hematological improvement since last dose of chemotherapy. (Concurrent hydroxyurea administration will be allowed to control WBC count, platelet count, or symptoms).
  • No active infections.
  • Negative pregnancy test for women of childbearing potential.
  • No uncontrolled psychiatric illness or medical illness that the principal investigator feels will compromise the patient's tolerance of the study medication.
  • Must provide informed consent.

Exclusion Criteria

  • Patients with an allergy to proton pump inhibitors, required for GI prophylaxis; or salicylates are excluded.
  • Pregnant or lactating women
  • Age <18 years. Because no dosing or adverse event data are currently available on the use of TPA alone or in combination with dexamethasone in patients < 18 years of age, children are excluded from this study but will be eligible for future pediatric Phase II combination trials.
  • The effects of TPA on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 10 weeks after. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Should the female partner of a participant in this study become pregnant or suspect she is pregnant during this study, the PI of this study will be available to provide advice about further medical/obstetric care/referral for the female partner.
  • Patients with active CNS involvement (documented by radiographic lesions and/or malignant cells in the CSF) will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Patients with treatment of any other investigational drug within the last 30 days prior to entering the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TPA + Dexamethasone and CMT
12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
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.
Other Names:
  • TPA
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.
Other Names:
  • 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 Names:
  • Trilisate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)
Time Frame: 42 months
42 months
Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%
Time Frame: 43 months
43 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression
Time Frame: 48 months
Cycle 1 of treatment
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Biosuccess Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020702
  • P30CA068485 (U.S. NIH Grant/Contract)
  • P30CA072720 (U.S. NIH Grant/Contract)
  • 0220080085 (Other Identifier: IRB #)
  • NCI-2011-03242 (Other Identifier: CTRP (Clinical Trails Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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