A Phase 1 Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced anti-Tumor Immunity In Patients with NY-ESO-1 Expressing Solid Tumors

• Prostate Cancer: Patients with metastatic, castrate refractory prostate cancer. The use of LHRH agonist is allowed.
• Kidney Cancer: Patients with metastatic kidney cancer. Prior therapies with cytokines, VEGF and mTOR inhibitors are allowed.
• Bladder Cancer: Patients with metastatic urothelial carcinoma. Prior cisplatin-based therapies are allowed.
• Ovarian Cancer: Eligible patients have asymptomatic residual measurable disease on physical examination and/or CT scan, and/or may have an elevated CA-125; or may be in complete clinical remission after treatment for primary or recurrent disease.
• Brain Tumors: Histologic proof of one of the following: glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic mixed glioma or anaplastic oligoastrocytoma. Patients who have had recent cranial surgery are eligible for inclusion, but the vaccine may not be administered prior to post-operative Day 14.
• Uterine Cancer: Patients with advanced (Stages II ‑ IV) or recurrent disease who have completed standard therapy, currently NED or with minimal residual disease. Patients with Stage I uterine serous carcinomas or sarcomas are also eligible after completion of standard therapy.
• Breast Cancer: Patients can enter study after completion of all chemotherapy (including trastuzumab), radiation, breast/axillary surgery. Patients may participate while on endocrine therapy. Stages I ‑ III patients with the following characteristics: (i) ER negative with positive lymph nodes; (ii) ER negative with negative nodes if tumor > 2 cm; (iii) ER positive with positive lymph nodes; and (iv) ER positive with negative lymph nodes and tumor > 5 cm.
• Sarcomas: Patients with sarcomas of any site, who have completed standard therapy, and are in remission, or have minimal disease burden.
• Lungs: (i) Resected patients with hilar or ipsilateral mediastinal nodal disease (i.e., a subset of patients with Stage II and IIIA disease); and (ii) Patients with residual disease on imaging after definitive radiation or chemoradiation therapy.
• Esophageal: (i) Resected patients with any nodal (i.e., thoracic or abdominal) disease; and (ii) Patients with residual disease on imaging after definitive chemoradiation therapy.
• Melanoma: (i) Stage IIB, Stage IIC, and Stage III who have completed planned definitive therapy for their disease including radiotherapy and/or interferon. Patients declining interferon or with contra-indications to interferon will also be eligible provided they meet requisite criteria for this study (i.e., non-measurable disease); (ii) Stage IV melanoma of M1a sub-type only, who are not candidates for additional therapy of curative potential (i.e., small volume disease; may be measurable or evaluable); and (iii) Stage IV melanoma, NED, s/p complete resection of known sites of disease (i.e., non-measurable disease).
• Hepatocellular Carcinoma: (i) Patients who have been treated with surgical resection for HCC; and (ii) following chemoembolization as adjuvant therapy for HCC.
• Gastrointestinal: Patients who have completed standard therapies for gastric and colorectal cancers, and deemed to be at high risk of relapse.

For more information please visit the ClinicalTrials.gov link.