Overview

Autophagy Inhibition to Augment Mammilian Target of Rapamycin (mTOR) Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine (HCQ) in Patients With Previously Treated Renal Cell Carcinoma

Status:
Completed

Trial end date:
2017-01-05

Target enrollment:

Participant gender:

Summary

This is an open labeled phase I dose escalation study of hydroxychloroquine (HCQ) and RAD001 in patients with advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target population are patients with one to three prior treatments for advanced renal cell carcinoma. In the phase I portion a traditional 3+3 design will be used to determine the maximal tolerated dose and/or recommended phase II dose for HCQ in combination with RAD001 po 10 mg/day.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Abramson Cancer Center of the University of Pennsylvania

Collaborators:

Rutgers Cancer Institute of New Jersey
University of Medicine and Dentistry of New Jersey, Cancer Institute of New Jersey
University of Pittsburgh
University of Pittsburgh, Hillman Cancer Center

Treatments:

Everolimus
Hydroxychloroquine
Sirolimus