Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: BB 1101; Carboplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Docetaxel; Lenograstim

Criteria

INCLUSION CRITERIA:

• Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease in whom the EBV-genome or antigens have been demonstrated in tissue biopsy samples

• Age 10 years or older

• Life expectancy of 8 weeks or more

• Karnofsky or Lansky score of 50 or more

• Normal bilirubin level (per institutional standard)

• AST and ALT 1.5 x or less upper limit of normal

• Alk Phos level less than 2.5 x upper limit of normal

• ANC greater than 1500 cells/ul

• Hgb 8.0 or greater

• Platelets 100,000 cells/ul or more

• Creatinine 2 x or less ULN or GFR 50 ml/min/1.73 m2 or more

• Women of child-bearing potential must take/use effective birth control while participating in the study.

EXCLUSION CRITERIA:

• Due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research.

• Prior allergic reaction to the study drugs used in this protocol or other drugs formulated with polysorbate 80.

• Known HIV positive subjects since treatment may be significantly immunosuppressive

• Women who are breast-feeding

• Severe intercurrent infection

• Patients, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study