Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
NCT01522820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2016-10-04
Summary
This phase I trial studies the side effects and best schedule of vaccine therapy with or without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. It is not yet known whether vaccine therapy works better when given with or without sirolimus in treating solid tumors.
Conditions
- Anaplastic Astrocytoma
- Anaplastic Oligoastrocytoma
- Anaplastic Oligodendroglioma
- Estrogen Receptor Negative
- Estrogen Receptor Positive
- Glioblastoma
- Hormone-Resistant Prostate Cancer
- Metastatic Prostate Carcinoma
- Metastatic Renal Cell Cancer
- Recurrent Adult Brain Neoplasm
- Recurrent Bladder Carcinoma
- Recurrent Breast Carcinoma
- Recurrent Colorectal Carcinoma
- Recurrent Esophageal Carcinoma
- Recurrent Gastric Carcinoma
- Recurrent Hepatocellular Carcinoma
- Recurrent Lung Carcinoma
- Recurrent Melanoma
- Recurrent Ovarian Carcinoma
- Recurrent Prostate Carcinoma
- Recurrent Renal Cell Carcinoma
- Recurrent Uterine Corpus Carcinoma
- Resectable Hepatocellular Carcinoma
- Sarcoma
- Stage IA Breast Cancer
- Stage IA Ovarian Cancer
- Stage IA Uterine Corpus Cancer
- Stage IB Breast Cancer
- Stage IB Ovarian Cancer
- Stage IB Uterine Corpus Cancer
- Stage IC Ovarian Cancer
- Stage II Uterine Corpus Cancer
- Stage IIA Breast Cancer
- Stage IIA Lung Carcinoma
- Stage IIA Ovarian Cancer
- Stage IIB Breast Cancer
- Stage IIB Esophageal Cancer
- Stage IIB Lung Carcinoma
- Stage IIB Ovarian Cancer
- Stage IIB Skin Melanoma
- Stage IIC Ovarian Cancer
- Stage IIC Skin Melanoma
- Stage IIIA Breast Cancer
- Stage IIIA Esophageal Cancer
- Stage IIIA Lung Carcinoma
- Stage IIIA Ovarian Cancer
- Stage IIIA Skin Melanoma
- Stage IIIA Uterine Corpus Cancer
- Stage IIIB Breast Cancer
- Stage IIIB Esophageal Cancer
- Stage IIIB Ovarian Cancer
- Stage IIIB Skin Melanoma
- Stage IIIB Uterine Corpus Cancer
- Stage IIIC Breast Cancer
- Stage IIIC Esophageal Cancer
- Stage IIIC Ovarian Cancer
- Stage IIIC Skin Melanoma
- Stage IIIC Uterine Corpus Cancer
- Stage IV Bladder Urothelial Carcinoma
- Stage IV Esophageal Cancer
- Stage IV Ovarian Cancer
- Stage IV Prostate Cancer
- Stage IV Skin Melanoma
- Stage IVA Uterine Corpus Cancer
- Stage IVB Uterine Corpus Cancer
Interventions
- BIOLOGICAL
-
DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Given intranodally
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Pharmacological Study
Correlative studies
- DRUG
-
Sirolimus
Given PO or PEG
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Kunle Odunsi · Roswell Park Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
Countries
- United States
Study Locations
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