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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

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.

Arms, Groups and Cohorts

  • Experimental: TPA + Dexamethasone and CMT
    • 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Collaborator
    • Rutgers Cancer Institute of New Jersey
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Roger Strair, MD, PhD, Principal Investigator, Rutgers Cancer Institute of New Jersey

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