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

NCT ID: NCT01009931

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TPA + Dexamethasone and CMT

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

Group Type: EXPERIMENTAL

12-O-tetradecanoylphorbol-13-acetate

Intervention Type: DRUG

The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.

Dexamethasone

Intervention Type: DRUG

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

Choline magnesium trisalicylate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TPA; Dexamethasone sodium phosphate; Trilisate

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Biosuccess Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Strair, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0220080085

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2011-03242

Identifier Type: OTHER

Identifier Source: secondary_id

020702

Identifier Type: -

Identifier Source: org_study_id