Status:
TERMINATED
A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma
Lead Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
Conditions:
Sarcoma
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief 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-...
Eligibility Criteria
Inclusion
- Patients with Soft tissue sarcoma (including high grade or low grade soft tissue sarcoma、osteogenic sarcoma and the following 4 recurrent benign tumors which may have aggressive clinical course after initial surgical treatment : lymphangioleiomyomatosis、angiomyolipoma、giant cell tumor、phylloid tumor) that are refractory to at least first line full course of standard chemotherapy, relapsed after standard chemotherapy, or who have no standard therapy available and refused chemotherapy
- Patients must be \>/= 21 years.
- Patients must be \>/= 4 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be \>/= 5 half-lives or \>/= 3 weeks form the last dose (whichever comes first).
- Eastern Cooperative Oncology Group(ECOG) performance status \</= 2
- Patients must have certain organ and marrow function resave defined as: White blood cell(WBC\_ \>/= 3,000/mL;platelets \>/=100,000/mL; creatinine \</= 2 X Upper Limit of Normal (ULN); total bilirubin \</= 2.0; Alanine Aminotransferase(ALT;SGPT) \</= 5 X ULN; Exception for patients with liver metastasis: total bilirubin \</= 3 x ULN; ALT(SGPT) \</= 8 X ULN;cholesterol \</= 350 mg/dL; triglycerides \</= 400 mg/dL (sirolimus and hydroxychloroquine only).
- Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion
- Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Pregnant or lactating women.
- History of hypersensitivity to sirolimus.
- History of hypersensitivity to hydroxychloroquine
- Patients unwilling or unable to sign informed consent document.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01842594
Start Date
August 1 2012
End Date
January 1 2015
Last Update
November 3 2015
Active Locations (1)
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1
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, Taiwan, 11101