Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Trial of The Combination of Vismodegib and Sirolimus
This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD) of the combination of vismodegib and
sirolimus in unresectable solid tumors. (Cohort I)
SECONDARY OBJECTIVES:
I. To describe the adverse event profile associated with this treatment combination.
II. To describe the tumor responses to treatment combination.
CORRELATIVE OBJECTIVES:
I. To assess the effect of the sirolimus and vismodegib combination on selected biomarkers in
tumor biopsies of patients with metastatic pancreatic cancer.
II. To assess the effect of the combination of vismodegib and sirolimus on fludeoxyglucose F
18 (F18-FDG) positron emission tomography (PET) or PET/computed tomography (CT) imaging in
Cohort II (MTD) patients with metastatic pancreatic cancer.
III. To study the association of clinical (toxicity and/or tumor response or activity) with
the biologic (pharmacodynamic) results obtained by examining tissue biopsies and PET or
PET/CT imaging from the same patients.
OUTLINE: This is a dose-escalation study of sirolimus.
Patients receive sirolimus orally (PO) once daily (QD) and vismodegib PO QD on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 months.
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