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

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ClinicalTrials.gov 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
Sponsor:
Collaborators:
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: 12-O-tetradecanoylphorbol-13-acetate
Drug: Dexamethasone
Drug: Choline magnesium trisalicylate
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TPA + Dexamethasone and CMT
Hide Arm/Group Description

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

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.

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.

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.

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Arm/Group Title TPA + Dexamethasone and CMT
Hide Arm/Group Description

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

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.

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.

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.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)
Hide Description [Not Specified]
Time Frame 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study participant died before the study data collection completed.
Arm/Group Title TPA + Dexamethasone and CMT
Hide Arm/Group Description:

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

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.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%
Hide Description [Not Specified]
Time Frame 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study participant died before the study data collection completed.
Arm/Group Title TPA + Dexamethasone and CMT
Hide Arm/Group Description:

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

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.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression
Hide Description Cycle 1 of treatment
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study participant died before the study data collection completed.
Arm/Group Title TPA + Dexamethasone and CMT
Hide Arm/Group Description:

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

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.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TPA + Dexamethasone and CMT
Hide Arm/Group Description

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

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.

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.

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.

All-Cause Mortality
TPA + Dexamethasone and CMT
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TPA + Dexamethasone and CMT
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
Hemorrhage, GI - Rectum  1/1 (100.00%)  1
General disorders   
Hemorrhage, CNS  1/1 (100.00%)  2
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood   1/1 (100.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TPA + Dexamethasone and CMT
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Tatiana Zelinskaya
Organization: Rutgers Cancer Institute of New Jersey
Phone: (732) 235-9837
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01009931     History of Changes
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 Submitted: November 6, 2009
First Posted: November 9, 2009
Results First Submitted: June 16, 2015
Results First Posted: June 22, 2015
Last Update Posted: November 4, 2015