Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

Lymphoma Clinical Trial

Official title: A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT01169532
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Completion date: March 2014