Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00204789
Other study ID # 2001-414
Secondary ID CO00318
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2003
Est. completion date December 2007

Study information

Verified date December 2007
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Difluoromethylornithine


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability for 12 months
Secondary To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50% for the 12 months of therapy
Secondary To determine if DFMO will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment
See also
  Status Clinical Trial Phase
Completed NCT00027586 - Imatinib Mesylate in Treating Patients With Metastatic Melanoma Phase 2
Not yet recruiting NCT02230462 - Patient Satisfaction After Facial Reconstruction N/A
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Completed NCT00224744 - Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage Phase 3
Completed NCT03132012 - Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection N/A
Terminated NCT00865878 - ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients Phase 2
Not yet recruiting NCT05359419 - Comparison of Two Modes of Photodynamic Therapy for the Treatment of Actinic Keratosis on the Upper Extremities Phase 4
Active, not recruiting NCT00001813 - Examination of Clinical and Laboratory Abnormalities in Patients With Defective DNA Repair: Xeroderma Pigmentosum, Cockayne Syndrome, or Trichothiodystrophy
Completed NCT02046811 - Reducing Skin Cancer Risk in Childhood Cancer Survivors N/A
Completed NCT02147080 - A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults N/A
Completed NCT00007631 - Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer Phase 3
Completed NCT00847912 - CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial Phase 4
Recruiting NCT02836548 - HDAC Inhibitor Vorinostat in Resistant BRAF V600 Mutated Advanced Melanoma Phase 1/Phase 2
Completed NCT01482104 - New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC) N/A
Enrolling by invitation NCT04630886 - Use of Tranexamic Acid in Reduction of Post-Op Complications in Mohs Micrographic Surgery Early Phase 1
Completed NCT03012581 - Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types Phase 2
Withdrawn NCT02813902 - A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors Phase 1
Not yet recruiting NCT02408835 - Negative Pressure Wound Therapy in Groin Dissection N/A
Completed NCT02310503 - Spanish Registry of Mohs Surgery
Active, not recruiting NCT04267861 - M7824 Related Adverse Effects in Adults With Cancer