Difluoromethylornithine (DFMO) Chemoprevention of Skin Ca... | NCT00204789

Studies
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients

NCT00204789

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Dec 16, 2019Actual

Enrollment

52Estimated

Phase

Phase 2

Conditions

Post-solid Organ Transplant
Skin Neoplasms

Interventions

Difluoromethylornithine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CO00318

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2003

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 16, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Name	Type	Description	Arm Group Labels	Other Names
Difluoromethylornithine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability		for 12 months

Secondary Outcomes

Measure	Description	Time Frame
To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%		for the 12 months of therapy
To determine if DFMO will be able to decrease polyamine levels in skin biopsies		for the 12 months of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard H Bailey, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012878	Skin Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000518	Eflornithine

Ancestor Terms

ID	Term
D009952	Ornithine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided