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

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

DRUG

Docetaxel

60 mg/m2 IV on Day 1

DRUG

Carboplatin

Target AUC of 5 (mg/ml x min) on Day 1

DRUG

Dexamethasone

5 mg/m2/dose (max of 8 mg/dose) po q hs on Day 0, and q am and hs on Day 1

BIOLOGICAL

EBV-specific cytotoxic T lymphocytes

1 x 10e8 cells/m2 IV over 1 to 5 min

BIOLOGICAL

G-CSF or Peg-GCSF

If needed per dose modification guidelines: Peg-GCSF 0.1 mg/kg ≤ 45 kg; 6 mg for \> 45 kg subcutaneous on Day 2 or GCSF 5 mcg/kg/day (max of 600 mcg) subcutaneous to start 24 hours after carboplatin administration until ANC \> 2500 cells/ul x 2 days after nadir.

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Chrystal U Louis, MD, MPH · Texas Children's Hospital; Baylor College of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2014-06-30

Completion

2015-07-31

FDA Drug

Yes

Countries

• United States

Study Locations