Post-solid Organ TransplantPhase 2NCT00204789
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
A Phase 2 study testing Difluoromethylornithine in people with Post-solid Organ Transplant and Skin Neoplasms, run by University of Wisconsin, Madison.
Trial summary
This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post-solid Organ Transplant, Skin Neoplasms
- What is being tested?
- Difluoromethylornithine
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney
- Adequate organ function
- Hearing age/gender appropriate
- At high risk for developing skin cancer
- Immunosuppressant levels and doses show stable graft function
Who cannot join
- Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA)
- Systemic therapy for cancer treatment or prophylaxis
- Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs [NSAIDs] (other than cardioprotective doses of aspirin)
About this study
Official title: Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.
- Conditions
- Post-solid Organ Transplant, Skin Neoplasms
- Being tested
- Difluoromethylornithine
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DifluoromethylornithineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
Measured: for 12 months
Secondary outcomes (2)
To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%
Measured: for the 12 months of therapy
To determine if DFMO will be able to decrease polyamine levels in skin biopsies
Measured: for the 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Howard H Bailey, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204789
- Sponsor's protocol ID
- 2001-414
- Other IDs
- CO00318
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 16 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
- ClinicalTrials.gov ID
- NCT00204789
- Acronym / sponsor ID
- 2001-414
- Conditions
- Post-solid Organ Transplant, Skin Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney
- Adequate organ function
- Hearing age/gender appropriate
- At high risk for developing skin cancer
- Immunosuppressant levels and doses show stable graft function
Key exclusion criteria (3 listed)
- Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA)
- Systemic therapy for cancer treatment or prophylaxis
- Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs [NSAIDs] (other than cardioprotective doses of aspirin)
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 |
|---|---|---|
| Difluoromethylornithine | Drug | – |
Primary outcome
To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
Time frame: for 12 months
2 secondary outcomes
To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%
Time frame: for the 12 months of therapy
To determine if DFMO will be able to decrease polyamine levels in skin biopsies
Time frame: for the 12 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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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.
Howard H Bailey, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Difluoromethylornithine in people with Post-solid Organ Transplant and Skin Neoplasms, run by University of Wisconsin, Madison.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability (time frame: for 12 months). 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 16 Dec 2019.