Hydroxychloroquine + Vorinostat in Advanced Solid Tumors

Inclusion Criteria

• •Patients must be at least 16 years of age
• •Patients must have a histologically confirmed non-hematological malignancy. Patients must have received and failed standard treatment for their malignancy; patients for whom no standard treatment is available will also be eligible.
• •Patients must have an ECOG PS at 0, 1, or 2
• •Patients must have adequate hematologic, renal and liver function (i.e. absolute Neutrophil count \> 1000/mm3, platelets \> 75,000/mm3); creatinine
• •* 2 times the upper limits of normal (ULN) total bilirubin ≤ 1.5 mg/dl, ALT and AST £ 3 times above the upper limits of the institutional norm ALT, AST can be \< 5 times upper limits of normal if patients have hepatic involvement.
• •Patients must be able to provide written informed consent.
• •Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant.
• •Complete supportive and palliative care will continue to be provided to ameliorate signs and symptoms that were pre-existing or may arise while on study and which do not interfere with the objectives of the study.
• •Tumor blocks available from previous surgery/biopsy.
• •At the tumor specific expansion, only patients with metastatic colorectal and renal cell cancers will be enrolled. Patients with metastatic colorectal and renal cancer must have been treated and progressed or intolerant to standard care therapy.
• •Patients with colorectal cancer must been treated in the past with Irinotecan and/or Oxaliplatin and/or AvastinIEGFR therapy or intolerant to these agents. No more than 4 lines of therapy permitted in the metastatic setting. Patients with colorectal cancer may enroll irrespective of K-Ras mutational status, although this will be documented.
• •Patients with renal cell cancer must have been treated with a VEGF targeted therapy and/or mTOR inhibitor. No more than 4 lines of therapy permitted in the metastatic setting.
• •Prior treatment with Vorinostat and HCQ are not permitted in each tumor type.