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TerminatedNCT01009931Updated Nov 4, 2015Results posted

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

A Phase 2 interventional study of 12-O-tetradecanoylphorbol-13-acetate and Dexamethasone in Leukemia, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-04.

Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment

Why this study was terminated
Study was terminated early due to lack of experimental medication (supply issues)
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Leukemia

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Keywords

  • Acute Myelogenous Leukemia
  • Relapsed AML
  • Refractory AML
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 1 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    TPA + Dexamethasone and CMT

    12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate)

    Drug: 12-O-tetradecanoylphorbol-13-acetate · Drug: Dexamethasone · Drug: Choline magnesium trisalicylate

Interventions

  • Drug12-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.

    Also known as: TPA

  • DrugDexamethasone

    Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.

    Also known as: Dexamethasone sodium phosphate

  • DrugCholine 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.

    Also known as: Trilisate

06

What researchers measure

Primary outcomes

  1. Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)

    Time frame: 42 months

  2. Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%

    Time frame: 43 months

Secondary outcomes

  1. Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression

    Cycle 1 of treatment

    Time frame: 48 months

07

Results

Posted Jun 22, 2015

Participant flow

Participant flow — Overall Study
MilestoneTPA + Dexamethasone and CMT
Started1
Completed0
Not completed1

Outcome measures

PrimaryResponse Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)
Time frame:
42 months

No measurements were reported for this outcome.

PrimaryGrade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%
Time frame:
43 months

No measurements were reported for this outcome.

SecondaryEffects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression

Cycle 1 of treatment

Time frame:
48 months

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TPA + Dexamethasone and CMT—1/1 (100%)0/1 (0%)
Most frequent serious events
Most frequent serious events
EventTPA + Dexamethasone and CMT
Infection with normal ANC or Grade 1 or 2 neutrophils - BloodInfections and infestations1/1
Hemorrhage, GI - RectumGastrointestinal disorders1/1
Hemorrhage, CNSGeneral disorders1/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)TPA + Dexamethasone and CMT
<=18 years0
Between 18 and 65 years0
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)TPA + Dexamethasone and CMT
Female1
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TPA + Dexamethasone and CMT
Hispanic or Latino0
Not Hispanic or Latino1
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TPA + Dexamethasone and CMT
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White1
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)TPA + Dexamethasone and CMT
United States1
08

Study locations

1 site
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01009931
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Biosuccess Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Nov 9, 2009
Start date
Mar 2011
Primary completion
Oct 2011
Completion
Sep 2014
Results posted
Jun 22, 2015
Last update
Nov 4, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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