Hydroxychloroquine + Vorinostat in Advanced Solid Tumors

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT01023737
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Solid Tumour

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    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.
  • Vorinostat — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2009
Status verified
Feb 2023
Primary completion
Dec 5, 2017
Completion
Jan 8, 2023

Study Design

Enrollment
72 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Therapy & Research Center University of Texas Health Science Center San AntonioSan AntonioTexas78229-

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Cancer Therapy & Research Center University of Texas Health Science Center San Antonio· San Antonio, TX

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