This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To determine which dose combinations of Ridaforolimus and Vorinostat are safe and tolerable. II. To define the maximum tolerated dose. III. To characterize dose limiting toxicities. SECONDARY OBJECTIVES: I. To describe the activity of this combination amongst all enrolled patients in terms of response rate, progression free survival and overall survival. II. To describe the activity of this combination in the subset of patients with RCC in terms of response rate, progression free survival and overall survival. III. To describe the pharmacodynamic effects of these agents in combination. OUTLINE: This is a dose escalation study. Patients receive ridaforolimus orally (PO) once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every three months for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States
Maximum Tolerated Dose (MTD)
MTD denoted as the highest dose at which no more than one of six patients experienced a dose limiting toxicity (DLT), and expanded to a total of 12 patients. Any drug-related grade 3 or 4 toxicity occurring during the first three weeks of treatment (except nausea, vomiting, diarrhea, serum lipid elevation, or transient electrolyte abnormality that resolved to a grade of 0-2 with medical management) was considered a dose limiting toxicity (DLT). Assessed by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0.
Time frame: First 3 weeks of treatment
Progression Free Survival
Kaplan Meier curves will be used. Proportions, 95% confidence intervals, and cumulative incidence curves will be used to characterize response rates.
Time frame: 1 year
Overall Survival
Kaplan Meier curves will be used. Proportions, 95% confidence intervals, and cumulative incidence curves will be used to characterize response rates.
Time frame: 1 year
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