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 — DRUGStarting dose of 200 mg by mouth every day for a 21 day cycle.
- Sirolimus — DRUGStarting dose of 2 mg by mouth every day for a 21 day cycle.
- Vorinostat — DRUGStarting 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 + SirolimusHydroxychloroquine 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 + VorinostatHydroxychloroquine 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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