Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
This study is an open label non randomized study of hydroxychloroquine (HCQ) with histone deacetylase (HDAC) inhibitor Vorinostat in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) and to evaluate the safety and antitumor activity of this drug combination.
Malignant Solid Tumour
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Inhibition of Autophagy in Solid Tumors: A Phase I Pharmacokinetic and Pharmacodynamic Study of Hydroxychloroquine in Combination With the HDAC Inhibitor Vorinostat for the Treatment of Patients With Advanced Solid Tumors With an Expansion Study in Advanced Renal and Colorectal Cancer|
- Maximum tolerated dose (MTD) of Hydroxychloroquine (HCQ) in combination with Vorinostat in patients with advanced solid tumors [ Time Frame: 6+ months, MTD is assessed during the 1st cycle ] [ Designated as safety issue: Yes ]
- To evaluate the safety and tolerability of HCQ in combination with Vorinostat in this patient population as determined by toxicity profile, incidence and rating according to NCI/CTC v3.0 criteria. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To evaluate the antitumor activity of HCQ in combination with Vorinostat as determined by response rate and progression free survival (exploratory) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Hydroxychloroquine and Vorinostat
Oral administration of Vorinostat will be begin on Cycle 1 Day 1 at 300mg and will be continued daily and HCQ will be administered starting on Day 2 of Cycle 1 and both will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
The HCQ study dose levels are defined as 400mg/day, 600mg/day, 800mg/day and 1000mg/day (oral dosing)during the phase I MTD determination. HCQ will be administered starting on Day 2 of Cycle 1 and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
Other Name: HCQDrug: Vorinostat
Oral administration of Vorinostat will be begin on Cycle 1 Day 1 at 300mg and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
Other Name: Suberoylanilide Hydroxamic Acid
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023737
|Contact: Epp Goodwinfirstname.lastname@example.org|
|United States, Texas|
|Cancer Therapy & Research Center University of Texas Health Science Center San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Epp Goodwin 210-450-5798 email@example.com|
|Principal Investigator: Devalingam Mahalingam, MD|
|Principal Investigator:||Devalingam Mahalingam, MD||University of Texas Health Science Center San Antonio|