Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01266057
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

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

Interventions

  • Hydroxychloroquine — DRUG
    Starting dose of 200 mg by mouth every day for a 21 day cycle.
  • Sirolimus — DRUG
    Starting dose of 2 mg by mouth every day for a 21 day cycle.
  • Vorinostat — DRUG
    Starting dose of 200 mg by mouth per day for a 21 day cycle.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of sirolimus or vorinostat that can be given in combination with hydroxychloroquine to patients with advanced cancer. The safety of these drug combinations will also be studied.

Key Dates

Start date
Apr 28, 2011
Status verified
Mar 2021
Primary completion
Feb 11, 2021
Completion
Feb 11, 2021

Study Design

Enrollment
143 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hydroxychloroquine + Sirolimus
    Hydroxychloroquine starting dose of 200 mg by mouth every day for a 21 day cycle. Sirolimus starting dose of 2 mg by mouth every day for a 21 day cycle.
  • Experimental: Hydroxychloroquine + Vorinostat
    Hydroxychloroquine starting dose of 200 mg by mouth every day for a 21 day cycle. Vorinostat starting dose of 200 mg by mouth per day for a 21 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Sirolimus or Vorinostat in Combination with Hydroxychloroquine in Participants with Advanced Cancers [ Time Frame: 21 day cycles, approximately 4 weeks for DLT assessment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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