A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Drug Refractory Advanced Sarcoma
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
Patients must meet all of the following inclusion criteria to be eligible for enrollment
into the study.
1. 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.
2. 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.
3. 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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The SUVmax change on PET/CT scan
The SUVmax change on PET/CT scan before and after treatment.
Taiwan: Department of Health