Recurrent cutaneous squamous cell carcinoma under rapamune.

Completed

• Registration Number: NL-OMON28449
• Lead Sponsor: Wyeth

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1. Organ (kidney or liver) transplant recipient with ³1 biopsy-confirmed cutaneous SCC;

2. Age ³18 years and at least 12 months post-transplantation;

Exclusion Criteria

1. Metastatic cutaneous SCC;

2. Other malignancies (except for other skin cancers), documented after transplantation;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the recurrence rate of biopsy-confirmed cutaneous SCC with sirolimus (SRL)-based immunosuppression over a 2 year period of follow-up.

Secondary Outcome Measures

Name	Time	Method
umber of hyperkeratotic skin lesions, located on: the dorsum of the hands, the forearms, the head.<br /><br /><br>Secondary Safety:<br /><br>1. Incidence and severity of biopsy-confirmed acute rejection;<br /><br>2. Treatment failure, defined as the occurrence of acute rejection or premature withdrawal from study medication for any reason;<br /><br>3. Differences in renal function as estimated by the Cockcroft-Gault equation in both renal and liver transplant recipients;<br /> <br>4. Patient and graft survival.