Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
Patients have a type of cancer called nasopharyngeal carcinoma (NPC) that has either come
back or not gone away after the best known standard treatments.
Most patients that respond to chemotherapy once their NPC tumors have come back have been
treated with a platinum-based medication like cisplatin. However, since many patients are
given cisplatin during their initial treatment for NPC, in this study, they will be treated
with another platinum-based chemotherapy medicine that has been used in patients with NPC
called carboplatin. In this study, carboplatin will be used in combination with another drug
called docetaxel. Other studies in patients with advanced head and neck cancer have shown
that docetaxel can cause tumors to respond better and allow patients to survive longer when
added to the standard treatments for those diseases.
Some patients with NPC show evidence of infection with the virus that causes infectious
mononucleosis, known as the Epstein Barr virus (EBV), before or at the time of their cancer
diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage
disease, suggesting that it may play a role in causing NPC. Previously, patients have been
treated with high-risk NPC using EBV-specific cytotoxic T cells. These cells are grown in the
laboratory and taught to recognize and attack EBV infected cells. In the past, patients were
either given the cells alone or just after they had received a medication to briefly lower
their white blood cell count. In both cases, many patients had their tumors shrink and in
some cases completely disappear after being treated with these EBV-specific cytotoxic T
cells.
Investigators have now decided to look at how patients with NPC and their tumors respond to
the treatment combination of chemotherapy and EBV-CTL. Patients are being asked to
participate in this study since the NPC tumor is associated with EBV and has either come back
or not responded to standard treatment. This combination of chemotherapy and EBV-CTLs is an
investigational treatment not approved by the Food and Drug Administration.
The purpose of this study is to see how relapsed or refractory, EBV-associated NPC tumors
respond when treated with carboplatin and docetaxel followed by EBV-CTL.
Phase:
Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine M.D. Anderson Cancer Center Texas Children's Hospital The Methodist Hospital Research Institute The Methodist Hospital System