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

This study is currently recruiting participants.
Verified June 2013 by Rutgers, The State University of New Jersey
Sponsor:
Collaborators:
Biosuccess Biotech Co., Ltd.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT01009931
First received: November 6, 2009
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: 12-O-tetradecanoylphorbol-13-acetate
Drug: Dexamethasone
Drug: Choline magnesium trisalicylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Response rate > 20% for 12-O-tetradecanoylphorbol-13- acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Grade 3 and 4 non-hematologic treatment-related toxicity rates < 25% [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects of treatment on immunophenotype, signaling profile, and nuclear NF-kB expression [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Cycle 1 of treatment


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Trilisate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009931

Contacts
Contact: Clinical Trials Office 732-235-8675

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey    732-235-8675      
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Biosuccess Biotech Co., Ltd.
Investigators
Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier: NCT01009931     History of Changes
Other Study ID Numbers: 020702, P30CA068485, 0220080085, P30CA072720
Study First Received: November 6, 2009
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Acute Myelogenous Leukemia
Relapsed AML
Refractory AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Hematologic Diseases
Choline
Dexamethasone
Sodium phosphate
Dexamethasone acetate
Choline magnesium trisalicylate
Salicylates
Dexamethasone 21-phosphate
BB 1101
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014