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Skin CancerPhase 4PROSKINNCT00866684

Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

A Phase 4 study testing Sirolimus, Azathioprine and Mycophenolate in people with Skin Cancer, run by Charite University, Berlin, Germany at 15 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Cancer
What is being tested?
Sirolimus, Azathioprine and Mycophenolate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
15 sitesGermany
Study dates
1 Jan 2007to 19 Apr 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
  • Age 18 years and older
  • Minimum period of 6 month after renal transplantation
  • Stable renal function and a calculated creatinine clearance of at least 40 ml/min
  • Written informed consent
  • Proteinuria ≤ 800 mg/d at time of enrolment
  • Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)

Who cannot join

  • Current Sirolimus- or Everolimus- intake
  • Instable graft function (creatinine clearance < 40 ml/min)
  • Graft rejection within the 3 previous months
  • Proteinuria > 800 mg/d
  • Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
  • Leucopenia < 2500/nl
Show all 15Show fewer
  • Thrombocytopenia < 90/nl
  • Pregnancy or breastfeeding
  • Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
  • Known allergy to macrolides
  • Current participation in other studies
  • Refusal to sign informed consent form
  • Neoplasm other than defined as inclusion criteria
  • All contraindications to SRL (see package insert, appendix)
  • Persons who are detained officially or legally to an official institute

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie

    Berlin, 10117

  • Kliniken der Stadt Köln, Medizinische Klinik I

    Cologne, North Rhine-Westphalia, 51109

  • Universitätsklinikum Erlangen, Hautklinik

    Erlangen, Bavaria, 91052

  • Universitätsklinikum Erlangen, Medizinische Klinik IV

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten

    Kiel, Schleswig-Holstein, 24105

  • Klinikum der LMU München, Medizinische Poliklinik Innenstadt

    München, Bavaria, 80336

  • Klinikum der LMU München, Klinik und Poliklinik für Dermatologie

    München, Bavaria, 80337

  • Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie

    München, Bavaria, 80802

  • Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik

    München, Bavaria, 81675

  • Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

    Münster, North Rhine-Westphalia, 48149

  • Universitätsklinikum Münster, Med. Klinik und Poliklinik D

    Münster, North Rhine-Westphalia, 48149

  • Universität Regensburg, Dermatologie

    Regensburg, Bavaria, 93053

  • Universität Regensburg, Nephrologie Innere Medizin II

    Regensburg, Bavaria, 93053

  • HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin

    Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

About this study

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

Read the detailed description

Patients who meet all inclusion criteria will be included into the study and randomised. If converted to SRL, patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Conditions
Skin Cancer
Being tested
Sirolimus, Azathioprine, Mycophenolate, Ciclosporin, Tacrolimus
Keywords
Renal transplant-patients with high-risk for skin cancer
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SirolimusDrug

    Also called Rapamune, ATC code: L04AA10

    Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day

  • AzathioprineDrug

    Also called ATC code: L04AX01

    control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month

  • MycophenolateDrug

    Also called ATC code: L04AA06

    Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month

  • CiclosporinDrug

    Also called ATC code: L04AA01

    Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month

  • TacrolimusDrug

    Also called ATC code: L04AA05

    Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month

Study groups in NCT00866684
Study groupRoleWhat they receive
1 SirolimusExperimentalPatients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Receives: Drug: Sirolimus
2 StandardActive comparatorPatients will stay on their previous immunosuppressive regimen.
Receives: Drug: Azathioprine; Drug: Mycophenolate; Drug: Ciclosporin; Drug: Tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Events of Reoccurrence of Skin Cancer

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study start1 Jan 2007
  3. Primary completion19 Apr 2011
  4. Study completion19 Apr 2011

Why it stopped: Insufficient patient recruitment

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866684
Sponsor's protocol ID
PROSKIN 01
Acronym
PROSKIN
Status last verified
Feb 2025
First submitted
19 Mar 2009
Last updated
14 Mar 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sirolimus, Azathioprine and Mycophenolate in people with Skin Cancer, run by Charite University, Berlin, Germany at 15 sites in Germany.

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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Events of Reoccurrence of Skin Cancer (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00866684.

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 14 Mar 2025.

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