Trial Outcomes & Findings for Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol (NCT NCT00866684)
NCT ID: NCT00866684
Last Updated: 2025-03-14
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
24 month
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
1 Sirolimus
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Sirolimus: Treatment arm Dosage:
adapted to serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (Tablets)
|
2 Standard
Patients will stay on their previous immunosuppressive regimen.
Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to serum level: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to serum level: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
19
|
|
Overall Study
COMPLETED
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Baseline characteristics by cohort
| Measure |
1 Sirolimus
n=25 Participants
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Sirolimus: Treatment arm Dosage adapted to serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (Tablets)
|
2 Standard
n=19 Participants
Patients will stay on their previous immunosuppressive regimen.
Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to serum level: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to serum level: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Continuous
|
64.4 years
n=99 Participants
|
59.6 years
n=107 Participants
|
61.68 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthProgression 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)
Outcome measures
| Measure |
1 Sirolimus
n=25 Participants
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Sirolimus: Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day
|
2 Standard
n=19 Participants
Patients will stay on their previous immunosuppressive regimen.
Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin: Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus: Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
|
|---|---|---|
|
Number of Events of Reoccurrence of Skin Cancer
|
25 Event
|
19 Event
|
Adverse Events
1 Sirolimus
Serious events: 15 serious events
Other events: 19 other events
Deaths: 0 deaths
2 Standard
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Sirolimus
n=25 participants at risk
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Sirolimus: Treatment arm Dosage adapted to Serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (tablet)
|
2 Standard
n=19 participants at risk
Patients will stay on their previous immunosuppressive regimen.
Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to Serum level 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to Serum level 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple squamous cell carcinomas
|
60.0%
15/25 • Number of events 25 • 2 years
|
36.8%
7/19 • Number of events 14 • 2 years
|
Other adverse events
| Measure |
1 Sirolimus
n=25 participants at risk
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Sirolimus: Treatment arm Dosage adapted to Serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (tablet)
|
2 Standard
n=19 participants at risk
Patients will stay on their previous immunosuppressive regimen.
Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to Serum level 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to Serum level 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
76.0%
19/25 • Number of events 60 • 2 years
|
47.4%
9/19 • Number of events 19 • 2 years
|
Additional Information
Prof. Dr. Petra Reinke
Charité Universitätsmedizin Berlin Augustenburger Platz 1 13353 Berlin
Phone: +49 30 450 653 490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place