Actinic KeratosisPhase 2NCT00089180
T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant
A Phase 2 study testing liposomal T4N5 lotion and laboratory biomarker analysis in people with Actinic Keratosis and Basal Cell Carcinoma of the Skin, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Actinic Keratosis, Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer
- What is being tested?
- liposomal T4N5 lotion and laboratory biomarker analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 34Show fewer
- 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
- No concurrent or planned therapy for the invasive malignancy
- Has an expected disease-free survival of at least 5 years
- No diagnosis of melanoma or melanoma in situ
- No other medical or psychosocial condition that would preclude study participation
- No likelihood, in the opinion of the transplant surgeon/nephrologist, to experience graft loss and/or discontinue standard immunosuppressive therapy during study treatment
- More than 30 days since prior and no concurrent topical chemotherapy (including topical fluorouracil) to areas being studied
- No concurrent topical preparations containing corticosteroids
- More than 30 days since prior and no concurrent local radiotherapy to a study area
- More than 30 days since prior and no concurrent cryotherapy to target lesions
- No prior or concurrent experimental immunosuppressive agents
- More than 30 days since prior investigational medication
- More than 30 days since prior and no concurrent systemic psoralens or retinoids
- More than 60 days since prior and no concurrent laser resurfacing, dermabrasion, or chemical peels to a study area
- No other concurrent investigational agents
- No other concurrent topical medications, including prescription and over the counter preparations, to the areas being studied (e.g., upper arms, forearms, neck, face, and scalp)
- Concurrent moisturizer, emollient, and sunscreen allowed
- No concurrent topical preparations containing vitamin A derivatives
- No concurrent nonsteroidal anti-inflammatory drugs
- Concurrent cardioprotective doses of aspirin (< 100 mg/day) allowed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
About this study
Official title: A Phase IIb Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Topical Bacteriophage T4 Endonuclease V in Renal Allograft Recipients With a History of Non-melanoma Skin Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the incidence of nonmelanoma skin cancer (NMSC) (average per patient) on the sun-exposed skin of renal transplant recipients with a history of NMSC treated with T4N5 liposomal lotion vs placebo.
SECONDARY OBJECTIVES:
- Compare the proportion of these patients who develop NMSC on sun-exposed skin during treatment and after cessation of treatment with these regimens.
II. Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation of treatment with these regimens.
III. Compare the incidence of recurrent and de novo actinic keratoses (AKs) in patients treated with these regimens.
IV. Determine whether either of these regimens induces regression of AKs left untreated on the sun-exposed skin of these patients.
- Compare the proportion of these patients who develop melanoma, in both treated and untreated sites, during and after cessation of treatment with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study center. Patients are randomized to 1 of 2 arms.
Six months before randomization, lesions suspicious for nonmelanoma skin cancer (NMSC) are surgically removed and histologically analyzed. All but 10 randomly selected non-suspicious lesions are removed. Of these 10 lesions, 5 are shave biopsied immediately pre-treatment for histologic and surrogate endpoint biomarker (SEB) analysis and to determine a baseline actinic keratosis: wart ratio. Patients also undergo a pre-treatment biopsy of normal appearing sun-exposed and non-sun-exposed skin (buttocks).
Arm I: 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.
Arm II: Patients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.
Treatment in both arms continues in the absence of the development of metastatic cutaneous squamous cell cancer or melanoma. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 6 months.
- Conditions
- Actinic Keratosis, Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin
- Being tested
- liposomal T4N5 lotion, placebo, laboratory biomarker analysis
- Medical subject headings
- Keratosis, Actinic, Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal T4N5 lotionDrug
Also called bacteriophage T4 endonuclease V in liposomal lotion, Dimericine, T4 endonuclease V liposomal lotion, T4N5 liposomal lotion
Given topically
placeboOther
Also called PLCB
Given topically
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: liposomal T4N5 lotion; Other: 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. Receives: Other: placebo; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Secondary outcomes (6)
Proportion of patients who develop NMSC during and after completion of study therapy
Calculated for the study drug and placebo arms and compared using the Fisher's exact or chi-square test.
Measured: Up to 18 months
Incidence of NMSC
Summarized by treatment arm and compared using the Wilcoxon rank-sum test.
Measured: Up to 18 months
Incidence of recurrent and de novo actinic keratoses (AKs) after completion of study therapy
Summarized by treatment arm and compared using the Wilcoxon rank-sum test. Similarly, multivariate Poisson regression model will be utilized to compare the cumulative number of incident AKs at the end of treatment as a function of treatment arm and covariates.
Measured: Up to 18 months
Number of regressed AKs after completion of study therapy
Summarized by treatment group and compared using the Wilcoxon rank-sum test. Similarly, multivariate Poisson regression model will be utilized to compare the cumulative number of regressed AKs at the end of treatment as a function of treatment group and covariates. In addition to the covariates listed above, the number of AKs at baseline will be included as a covariate in the model.
Measured: At 18 months
Risk of developing melanoma in both treated and untreated sites
The data will be collected and analyzed by scoring both total body melanoma distribution and those in lotion treatment sites. Relative risk will be calculated for the development of melanomas. The Chi-Square test will be used to explore the risk relationships.
Measured: Up to 18 months
Change in SEBs levels
Descriptive statistics will be calculated at baseline and end of treatment for several SEBs by treatment arm. The change in SEB levels will be also calculated for each patient and compared between treatment arms using either the two-sample t-test or Wilcoxon rank-sum test.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startMar 2004
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Craig Elmets, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089180
- Sponsor's protocol ID
- NCI-2012-02619
- Other IDs
- UAB-0323, CDR0000378098, N01CN15136
- Status last verified
- Jun 2013
- First submitted
- 4 Aug 2004
- Last updated
- 4 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Topical Bacteriophage T4 Endonuclease V in Renal Allograft Recipients With a History of Non-melanoma Skin Cancer
- ClinicalTrials.gov ID
- NCT00089180
- Acronym / sponsor ID
- NCI-2012-02619
- Conditions
- Actinic Keratosis, Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2004
- Primary completion
- Jan 2007 (actual)
- First posted
- 5 Aug 2004 (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 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.
Detailed description
PRIMARY OBJECTIVES:
- Compare the incidence of nonmelanoma skin cancer (NMSC) (average per patient) on the sun-exposed skin of renal transplant recipients with a history of NMSC treated with T4N5 liposomal lotion vs placebo.
SECONDARY OBJECTIVES:
- Compare the proportion of these patients who develop NMSC on sun-exposed skin during treatment and after cessation of treatment with these regimens.
II. Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation of treatment with these regimens.
III. Compare the incidence of recurrent and de novo actinic keratoses (AKs) in patients treated with these regimens.
IV. Determine whether either of these regimens induces regression of AKs left untreated on the sun-exposed skin of these patients.
- Compare the proportion of these patients who develop melanoma, in both treated and untreated sites, during and after cessation of treatment with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study center. Patients are randomized to 1 of 2 arms.
Six months before randomization, lesions suspicious for nonmelanoma skin cancer (NMSC) are surgically removed and histologically analyzed. All but 10 randomly selected non-suspicious lesions are removed. Of these 10 lesions, 5 are shave biopsied immediately pre-treatment for histologic and surrogate endpoint biomarker (SEB) analysis and to determine a baseline actinic keratosis: wart ratio. Patients also undergo a pre-treatment biopsy of normal appearing sun-exposed and non-sun-exposed skin (buttocks).
Arm I: 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.
Arm II: Patients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.
Treatment in both arms continues in the absence of the development of metastatic cutaneous squamous cell cancer or melanoma. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (liposomal T4N5 lotion) | Experimental | Drug: liposomal T4N5 lotion, Other: laboratory biomarker analysisPatients apply T4N5 liposomal lotion topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: laboratory biomarker analysisPatients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- History of histologically confirmed nonmelanoma skin cancer
- Renal transplant recipient ≥ 4 years ago
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| liposomal T4N5 lotionAlso: bacteriophage T4 endonuclease V in liposomal lotion, Dimericine, T4 endonuclease V liposomal lotion, T4N5 liposomal lotionGiven topically | Drug | Arm I (liposomal T4N5 lotion) |
| placeboAlso: PLCBGiven topically | Other | Arm II (placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (liposomal T4N5 lotion), Arm II (placebo) |
Primary outcome
Incidence of nonmelanoma skin cancer (NMSC)
Time frame: Up to 18 months
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.
6 secondary outcomes
Proportion of patients who develop NMSC during and after completion of study therapy
Time frame: Up to 18 months
Incidence of NMSC
Time frame: Up to 18 months
Incidence of recurrent and de novo actinic keratoses (AKs) after completion of study therapy
Time frame: Up to 18 months
Number of regressed AKs after completion of study therapy
Time frame: At 18 months
Risk of developing melanoma in both treated and untreated sites
Time frame: Up to 18 months
Change in SEBs levels
Time frame: From baseline to 12 months
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 4 Dec 2015.
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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.
Craig Elmets principal investigator
University of Alabama at Birmingham
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 liposomal T4N5 lotion and laboratory biomarker analysis in people with Actinic Keratosis and Basal Cell Carcinoma of the Skin, run by National Cancer Institute (NCI) 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 34 inclusion and 0 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 4 Dec 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. Some participants in this study may receive a placebo. 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?
Incidence of nonmelanoma skin cancer (NMSC) (time frame: Up to 18 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 4 Dec 2015.