Autophagy inhibition to augment mTOR inhibition: A phase I/II trial of RAD001 and hydroxychloroquine in patients with previously treated renal cell carcinoma

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Autophagy inhibition to augment mTOR inhibition: A phase I/II trial of RAD001 and hydroxychloroquine in patients with previously treated renal cell carcinoma

Primary Objective Phase I
To determine the maximum tolerated dose of HCQ when administered with daily RAD001 in patients with advanced RCC.
Primary Objective Phase II

To estimate the rate of 6 month PFS in RCC patients receiving RAD001 and HCQ who have had between 1 and 3 prior treatment regimens for advanced disease.

Secondary Objectives
1) To estimate the response rate of this combination.
2) To measure evidence of autophagy inhibition by EM and LC3, p62 immunoblotting in PBMC and tumor tissue
3) To define significant associations between baseline composite p-p70S6K/pAKt score (14) and PFS or response. To characterize significant associations between baseline genetic mutations and outcome and associations between baseline expression of LC3, p62, ATG5 and Beclin and clinical outcome.

Protocol Number081203
Principal InvestigatorMark Stein
PhasePhase I/II
ScopeLocal
Applicable Disease SitesKidney
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedRAD001 (Everolimus)
Hydroxychloroquine
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.