A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT01842594|
Recruitment Status : Terminated (Most patients completed only the primary objective (PET) and not went throught the secondary outcome (efficacy phase) of 8wks period.)
First Posted : April 29, 2013
Results First Posted : November 3, 2015
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Sirolimus and hydroxychloroquine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Sirolimus and hydroxychloroquine
Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally once daily(QD) for 2 cycles . Each treatment cycle is 28 days.
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.
- The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan [ Time Frame: 2 Weeks ]A baseline whole-body [18F]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second [18F]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response.
- The Toxicity [ Time Frame: 2 Weeks ]Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842594
|Shin Kong Wu Ho-Su Memorial Hospital|
|Taipei, Taiwan, 11101|