Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes (CADEN)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Drug: Docetaxel Drug: Carboplatin Drug: Dexamethasone Biological: EBV-specific cytotoxic T lymphocytes |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
- 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 ] [ Designated as safety issue: Yes ]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.
- Response to re-induction chemotherapy [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Evaluation of immune response by measuring EBV-DNA levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: Chemotherapy and Immunotherapy
|
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 108 cells/m2 IV
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 or uncontrolled condition
- 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| Contact: Chrystal U Louis, MD, MPH | 832-824-4809 | culouis@txch.org |
| Contact: Catherine S Perera | 832-824-4594 | csperera@txch.org |
| United States, Texas | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Helen Heslop, MD 832-824-4662 heheslop@txch.org | |
| Contact: Catherine S Perera 832-824-4594 csperera@txch.org | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Chrystal U Louis, MD, MPH 832-824-4809 culouis@txch.org | |
| Contact: Catherine S Perera 832-824-4594 csperera@txch.org | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Bonnie Glisson, MD 713-792-6363 bglisson@mdanderson.org | |
| Contact: Catherine S Perera 832-824-4594 csperera@txch.org | |
| Principal Investigator: Bonnie Glisson, MD | |
| Principal Investigator: | Chrystal U Louis, MD, MPH | Texas Children's Hospital; Baylor College of Medicine |
More Information
No publications provided
| 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 |
| Study First Received: | August 4, 2009 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Baylor College of Medicine:
|
nasopharyngeal carcinoma Carboplatin Docetaxel |
Epstein-Barr Virus T Lymphocytes EBV-CTLs |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Dexamethasone acetate Dexamethasone |
Dexamethasone 21-phosphate Docetaxel Carboplatin BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 16, 2013