A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma
Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma|
- The SUVmax change on PET/CT scan [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]The SUVmax change on PET/CT scan before and after treatment.
- Tumor response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Determine the objective response rate in sarcoma patients treated with daily morning single dose of hydroxychloroquine 400 mg and sirolimus 2mg for 8 weeks.
- The toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The toxicity of hydroxychloroquine and sirolimus in this patient population.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Experimental: Sirolimus and hydroxychloroquine||
Drug: Sirolimus and hydroxychloroquine
Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally QD for 2 cycles .
Each treatment cycle is 28 days.
This study evaluates the daily morning single dose of hydroxychloroquine /sirolimus combined therapy in sarcoma patients. Study arm were treated with hydroxychloroquine 400 mg /sirolimus 2mg gd for 8-wk therapy. Patients will be discontinued from the study after 8-wk observation period.
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally every day. Treatment will be divided into time periods called cycles. Each treatment cycle is 28 days. The exception to this 28 day cycle is when participants start taking the pills for the first time. When the hydroxychloroquine and sirolimus begins, the first cycle of 28 days begins.
- There are several tests and procedures that will be performed at specific time periods during protocol treatment. These include: blood work, performance status assessment, questions about medical history and medications, tumor assessment with PET/CT or MRI and, eye exams.
- Dose modification criteria:
Participants may continue to receive study treatment as long as they experienced grade 1 or 2 side effects. The treatment drug will be 50% reduction of dose in any grade 3 toxicity; and discontinued of treatment (off-study) in any grade 4 toxicity or disease progression during treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842594
|Contact: Kwan-Hwa Chi, M.D.||886-2-28332211 ext 2273||M006565@ms.skh.org.tw|
|Contact: Yu-Shan Wang, Ph.D||886-2-28332211 ext 2614||T006659@ms.skh.org.tw|
|Shin Kong Wu Ho-Su Memorial Hospital||Recruiting|
|Taipei, Taiwan, 11101|
|Contact: Su-Chen Huang, M.S. 886-2-28332211 ext 2612 A007267@ms.skh.org.tw|
|Principal Investigator: Kwan-Hwa Chi, M.D.|