drugset / Trial / NCT01522820
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
Phase 1
Completed
18 enrolled
Roswell Park Cancer Institute
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-03
- Primary completion
- 2016-07
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RASDEGAFUSP ALFA | Vaccine | — | Other |
| Subject | Sirolimus | Small molecule | — | Oral |
Indications
anaplastic astrocytoma
anaplastic oligoastrocytoma
anaplastic oligodendroglioma
brain neoplasm
carcinoma of esophagus
colorectal carcinoma
cutaneous melanoma
estrogen-receptor negative breast cancer
estrogen-receptor positive breast cancer
female breast carcinoma
gastric carcinoma
glioblastoma
hepatocellular carcinoma
hormone-resistant prostate carcinoma
lung carcinoma
metastatic prostate carcinoma
ovarian carcinoma
renal cell adenocarcinoma
sarcoma
urinary bladder carcinoma
urothelial carcinoma
uterine carcinoma
uterine corpus cancer