NCT00089180

Brief Summary

This randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant. Chemoprevention therapy is the use of certain drugs to try to prevent the development of or recurrence of cancer. T4N5 liposomal lotion may be effective preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

December 4, 2015

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

August 4, 2004

Last Update Submit

December 3, 2015

Conditions

Actinic KeratosisBasal Cell Carcinoma of the SkinRecurrent Skin CancerSquamous Cell Carcinoma of the Skin

Outcome Measures

Primary Outcomes (1)

  • Incidence of nonmelanoma skin cancer (NMSC)

    Descriptive statistics such as mean, median, standard deviation will be calculated to summarize the number of new NMSC for each of the two randomization arms and compared using the Wilcoxon rank-sum test.

    Up to 18 months

Secondary Outcomes (6)

  • Proportion of patients who develop NMSC during and after completion of study therapy

    Up to 18 months

  • Incidence of NMSC

    Up to 18 months

  • Incidence of recurrent and de novo actinic keratoses (AKs) after completion of study therapy

    Up to 18 months

  • Number of regressed AKs after completion of study therapy

    At 18 months

  • Risk of developing melanoma in both treated and untreated sites

    Up to 18 months

  • +1 more secondary outcomes

Study Arms (2)

Arm I (liposomal T4N5 lotion)

EXPERIMENTAL

Patients apply T4N5 liposomal lotion topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.

Drug: liposomal T4N5 lotionOther: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.

Other: placeboOther: laboratory biomarker analysis

Interventions

liposomal T4N5 lotionDRUG

Given topically

Also known as: bacteriophage T4 endonuclease V in liposomal lotion, Dimericine, T4 endonuclease V liposomal lotion, T4N5 liposomal lotion
Arm I (liposomal T4N5 lotion)
placeboOTHER

Given topically

Also known as: PLCB
Arm II (placebo)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (liposomal T4N5 lotion)Arm II (placebo)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of histologically confirmed nonmelanoma skin cancer
  • Renal transplant recipient ≥ 4 years ago
  • Currently receiving standard multi-agent pharmacologic immunosuppression
  • Fitzpatrick skin type I, II, or III
  • Sun-damaged skin with ≥ 10 lesions consistent with actinic keratoses OR wart on the upper extremities (arms, forearms, hands), neck, face, and exposed scalp combined
  • No history of keloid formation
  • No known photosensitivity disorder
  • No history of malignant melanoma
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No diagnosis of acute allograft rejection within the past 30 days requiring an increase in immunosuppression
  • No invasive malignancy within the past 4 years except curatively excised NMSC, cured polyclonal posttransplantation lymphoproliferative disease, carcinoma in situ of the cervix, stage 0 chronic lymphocytic leukemia, unless all of the following criteria are met:
  • No current evidence of disease
  • No treatment for the invasive malignancy within the past 6 months
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Keratosis, ActinicCarcinoma, Basal CellSkin Neoplasms

Interventions

Deoxyribonuclease (Pyrimidine Dimer)endonuclease V, phage T4

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal CellNeoplasms by Site

Intervention Hierarchy (Ancestors)

EndodeoxyribonucleasesDeoxyribonucleasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Craig Elmets

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

March 1, 2004

Primary Completion

January 1, 2007

Last Updated

December 4, 2015

Record last verified: 2013-06

Locations

US(1)