A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas
Sponsored by Hoffmann-La Roche, patients will receive vismodegib
150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks. The outcome measure is relative reduction (%) from baseline in the number of clinically evident basal cell carcinomas at Week 73 (after 72 weeks of treatment).
Subjects who qualify must meet several criteria. Adult patients, >/= 18 years of age. Patients with multiple basal cell carcinomas, including patients with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, at least 3 of which measure 5 mm or more in diameter (target lesions). They must have a histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma; an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; and an adequate renal and hepatic function and hematopoietic capacity. Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 7 months after completion of study treatment, and male patients with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment.
Exclusion criteria include: inability or unwillingness to swallow capsules, pregnant or breastfeeding women, any metastatic basal cell carcinoma, locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery, and recent (ie within the past 28 days prior to randomization) or current participation in another experimental drug study.
A Phase II Study of Sirolimus in Renal Transplant Patients Diagnosed With New or Recurrent Squamous Cell Skin Carcinoma Currently on Calcineurin- based Immunosuppression
Sponsored by the University of Florida, this study is looking to see if Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in contrast to the general population
with basal and squamous cell skin cancer. The use of immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the risk of developing certain kinds of cancer. The purpose of this study is to compare sirolimus (an immunosuppressant drug) and calcineurin inhibitors (CNIs: also immunosuppressant drugs) and how they affect invasive squamous
cell carcinomas in renal transplant patients.
This is a Phase II randomized study to evaluate the effectiveness
of sirolimus in treating and preventing squamous cell skin cancer carcinoma using a Simon's 2-stage design. Once a pathological
diagnosis of squamous cell skin carcinoma has been made and patients consent, they will be randomized to either continue on their current immunosuppressive regimen or switch to sirolimus. The patients will participate in the study for one year. They will be seen once a week over the first 3 weeks of the study to evaluate immunosuppressant drug levels. At week 5 of the study, or sooner if determined by dermatology, patients will receive surgery to treat their squamous cell carcinomas. Patients will continue to be evaluated by dermatology for new skin cancers
every 3 months for 1 year.
Subjects may be excluded if: they had major surgery within 4 week prior to starting study drug, chronic or non-healing open wounds, are pregnant or nursing, or had a prior use of an mTOR inhibitor.
