LeukemiaPhase 2NCT01009931
Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies
A Phase 2 study testing 12-O-tetradecanoylphorbol-13-acetate, Dexamethasone and Choline magnesium trisalicylate in people with Leukemia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- 12-O-tetradecanoylphorbol-13-acetate, Dexamethasone and Choline magnesium trisalicylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
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
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
- Being tested
- 12-O-tetradecanoylphorbol-13-acetate, Dexamethasone, Choline magnesium trisalicylate
- Keywords
- Acute Myelogenous Leukemia, Relapsed AML, Refractory AML
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-O-tetradecanoylphorbol-13-acetateDrug
Also called TPA
The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.
DexamethasoneDrug
Also called Dexamethasone sodium phosphate
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 trisalicylateDrug
Also called Trilisate
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.
| Study group | Role | What they receive |
|---|---|---|
| TPA + Dexamethasone and CMT | Experimental | 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) Receives: Drug: 12-O-tetradecanoylphorbol-13-acetate; Drug: Dexamethasone; Drug: Choline magnesium trisalicylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)
Measured: 42 months
Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%
Measured: 43 months
Secondary outcomes (1)
Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression
Cycle 1 of treatment
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionSep 2014
Why it stopped: Study was terminated early due to lack of experimental medication (supply issues)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Biosuccess Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Roger Strair, MD, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009931
- Sponsor's protocol ID
- 020702
- Other IDs
- P30CA068485, 0220080085, P30CA072720, NCI-2011-03242
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2009
- Last updated
- 4 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01009931
- Acronym / sponsor ID
- 020702
- Conditions
- Leukemia
- Keywords
- Acute Myelogenous Leukemia, Relapsed AML, Refractory AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to lack of experimental medication (supply issues)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Biosuccess Biotech Co., Ltd.
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Posted 22 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPA + Dexamethasone and CMT | Experimental | Drug: 12-O-tetradecanoylphorbol-13-acetate, Drug: Dexamethasone, Drug: Choline magnesium trisalicylate12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-O-tetradecanoylphorbol-13-acetateAlso: TPAThe initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles. | Drug | TPA + Dexamethasone and CMT |
| DexamethasoneAlso: Dexamethasone sodium phosphateDexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles. | Drug | TPA + Dexamethasone and CMT |
| Choline magnesium trisalicylateAlso: TrilisateCholine 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. | Drug | TPA + Dexamethasone and CMT |
Primary outcome
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
1 secondary outcome
Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression
Time frame: 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Strair, MD, PhD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 12-O-tetradecanoylphorbol-13-acetate, Dexamethasone and Choline magnesium trisalicylate in people with Leukemia, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate) (time frame: 42 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.