A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: Sirolimus and hydroxychloroquine
Intervention description: 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.
Intervention MeSH terms: Sirolimus; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Sarcoma, Hydroxychloroquine, Sirolimus, PET

Summary:

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

Eligibility 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 </= 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 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.