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

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ClinicalTrials.gov Identifier: NCT00953420
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Docetaxel Drug: Carboplatin Drug: Dexamethasone Biological: EBV-specific cytotoxic T lymphocytes Biological: G-CSF or Peg-GCSF Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes in Patients With Refractory/Relapsed EBV-positive Nasopharyngeal Carcinoma(CADEN)
Study Start Date : November 2009
Primary Completion Date : June 2014
Study Completion Date : July 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Chemotherapy and Immunotherapy
  1. Docetaxel 60 mg/m2 IV on Day 1
  2. Carboplatin with target AUC of 5 (mg/ml x min) on Day 1
  3. Dexamethasone 5 mg/m2/dose (max of 8 mg/dose) po q hs on Day 0, and q am and hs on Day 1
  4. After cycle 1, subsequent cycles of chemotherapy may start once ANC > 1000 and platelets > 100,000 post nadir
  5. Up to an additional 2 cycles of chemotherapy, given per the above schedule, may be given if the EBV-specific cytotoxic T lymphocytes product is not available after the initial 4 cycles
Drug: Docetaxel
60 mg/m2 IV on Day 1
Other Name: Taxotere
Drug: Carboplatin
Target AUC of 5 (mg/ml x min) on Day 1
Other Name: Paraplatin
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
Other Name: Decadron
Biological: EBV-specific cytotoxic T lymphocytes
1 x 10e8 cells/m2 IV over 1 to 5 min
Other Name: EBV-specific cytotoxic T lymphocytes 1 x 10e8 cells/m2 IV
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.
Other Name: Filgrastim or pegylated filgrastim

Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint of the study is to evaluate the overall response rate for patients with advanced-stage, relapsed/refractory, EBV positive nasopharyngeal carcinoma after re-induction chemotherapy and immunotherapy. [ Time Frame: 3 months ]
    The overall response rate for patients with advanced-stage, relapsed/refractory, EBV positive nasopharyngeal carcinoma after re-induction chemotherapy (treatment with docetaxel and carboplatin) followed by immunotherapy with EBV-specific Cytotoxic T lymphocytes will be measured. Response rates will be estimated as the percent of patients whose best response is a CR or PR, and a 95% confidence interval will be calculated for the fraction of responses obtained.To measure the overall response rate, disease will be determined by imaging (MRI, CT, and/or PET imaging) 8 weeks after immunotherapy. In addition, per standard of care, disease re-evaluation will continue 3 months during the first year after participation and then as clinically indicated per the patient's primary oncologist.

Secondary Outcome Measures :
  1. Response to re-induction chemotherapy [ Time Frame: 8 weeks ]
  2. Evaluation of immune response by measuring EBV-DNA levels [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953420

United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
M.D. Anderson Cancer Center
Principal Investigator: Chrystal U Louis, MD, MPH Texas Children's Hospital; Baylor College of Medicine
More Information

Responsible Party: Chrystal Louis, Assistant Professor Pediatrics-Hem-Onc Cell & Gene, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00953420     History of Changes
Other Study ID Numbers: 25145-CADEN
CADEN ( Other Identifier: Baylor College of Medicine )
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chrystal Louis, Baylor College of Medicine:
nasopharyngeal carcinoma
Epstein-Barr Virus
T Lymphocytes

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors