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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009931
Recruitment Status : Terminated (Study was terminated early due to lack of experimental medication (supply issues))
First Posted : November 9, 2009
Results First Posted : June 22, 2015
Last Update Posted : November 4, 2015
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Biosuccess Biotech Co., Ltd.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : September 2014

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 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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression [ Time Frame: 48 months ]
    Cycle 1 of treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009931

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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Biosuccess Biotech Co., Ltd.
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Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
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Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT01009931    
Other Study ID Numbers: 020702
P30CA068485 ( U.S. NIH Grant/Contract )
0220080085 ( Other Identifier: IRB # )
P30CA072720 ( U.S. NIH Grant/Contract )
NCI-2011-03242 ( Other Identifier: CTRP (Clinical Trails Reporting Program) )
First Posted: November 9, 2009    Key Record Dates
Results First Posted: June 22, 2015
Last Update Posted: November 4, 2015
Last Verified: November 2015
Keywords provided by Rutgers, The State University of New Jersey:
Acute Myelogenous Leukemia
Relapsed AML
Refractory AML
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Dexamethasone acetate
Choline magnesium trisalicylate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipotropic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Nootropic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic