Trial Outcomes & Findings for Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma (NCT NCT01764607)
NCT ID: NCT01764607
Last Updated: 2018-11-14
Results Overview
Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Baseline, time of surgical removal (5 weeks) and 1 year.
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
Sirolimus Treatment
Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
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|---|---|
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Overall Study
STARTED
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1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma
Baseline characteristics by cohort
| Measure |
Sirolimus Treatment
n=1 Participants
Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
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Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, time of surgical removal (5 weeks) and 1 year.Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.
Outcome measures
| Measure |
Sirolimus Treatment
n=1 Participants
Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
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|---|---|
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Measure of Squamous Cell Skin Carcinoma in Patients
Measurement at Baseline
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15 mm
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Measure of Squamous Cell Skin Carcinoma in Patients
Measurement at 5 Weeks
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12 mm
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Measure of Squamous Cell Skin Carcinoma in Patients
Measurement at 1 Year
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0 mm
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SECONDARY outcome
Timeframe: At baseline and time of surgical removal (5 weeks).Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.
Outcome measures
| Measure |
Sirolimus Treatment
n=1 Participants
Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
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|---|---|
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Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma
|
80 percentage of baseline size
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Adverse Events
Sirolimus Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sirolimus Treatment
n=1 participants at risk
Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
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|---|---|
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Cardiac disorders
Hypertension
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
100.0%
1/1 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place