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

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Treatments: Everolimus; Hydroxychloroquine; Sirolimus

Criteria

Inclusion Criteria:

• 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
• Patients must have certain organ and marrow function resave defined as: White blood cell(WBC_ >/= 3,000/mL;platelets >/=100,000/mL; creatinineNormal (ULN); total bilirubinException for patients with liver metastasis: total bilirubinhydroxychloroquine only).

• Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

• 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.