NCT01842594

A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus.

Detailed description

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. TREATMENT PLAN: 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 during treatment.

Conditions

• Sarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-04-29
• Last updated: 2015-11-03
• Results posted: 2015-11-03

Locations

1 site across 1 country: Taiwan