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Most patients completed only the primary objective (PET) and not went throught the secondary outcome (efficacy phase) of 8wks period.
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Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus and hydroxychloroquine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus and hydroxychloroquine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan | 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. | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Toxicity | Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0. | 2 Weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | Taiwan | 11101 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26375670 | Derived | Chi MS, Lee CY, Huang SC, Yang KL, Ko HL, Chen YK, Chung CH, Liao KW, Chi KH. Double autophagy modulators reduce 2-deoxyglucose uptake in sarcoma patients. Oncotarget. 2015 Oct 6;6(30):29808-17. doi: 10.18632/oncotarget.5060. |
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Subjects were enrolled between August 2012 and June 2014 at Department of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus and Hydroxychloroquine | Patients received 1 mg of sirolimus (rapamycin, Rapa) and 200 mg of hydroxychloroquine (HCQ) twice a day before a meal for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus and Hydroxychloroquine | Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan | 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. | Posted | Mean | 95% Confidence Interval | percentage of the SUVmax Change | 2 Weeks | lesions | Participants |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sirolimus and Hydroxychloroquine | Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kwan-Hwa Chi | Shin Kong Wu Ho-Su Memorial Hospital | +886-28332211 | 2612 | M006565@ms.skh.org.tw |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002738 | Chloroquine |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. |
|
|
| Secondary | The Toxicity | Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0. | Posted | Number | participants | 2 Weeks |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D000634 |
| Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |