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EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) Clinical research trials and EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC). EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) clinical trial. Test subjects typically obtain the finest healthcare available for their EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)  EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
For Condition: Nasopharyngeal Cancer,EBV Infections
Status: Recruiting
Sponsor(s): Baylor College of Medicine , The Methodist Hospital,Texas Children's Hospital
Synopsis: The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells given after antibody injections, to learn what the side effects are and to see whether this therapy might help patients with nasopharyngeal cancer.
Details: Three different doses of CTL will be evaluated: dose level I: 2 doses of 2 x 10E7/m2 dose level II: 2 doses of 6 x 10E7/m2 dose level III: 2 doses of 1.5 x 10E8/m2 Three to six patients will be evaluated on each dosing schedule. Each patient will receive two CTL infusions eight weeks apart. The first CTL dose will be given without antibody. After monitoring for 8 weeks patients will receive CD45 monoclonal antibody. A fixed Dose of CD45 MAb will be used determined from our previous and ongoing studies in stem cell transplant recipients: 400ug/kg over 4 hrs daily x 4. CD45 levels will be monitored and two days later patients will receive a second CTL infusion at the same dose as the first infusion. (provided CD45 antibody level <100). If the CD45 level is greater than 100 it will be monitored daily and the cells given when it is less than 100. Day - 5 CD45 Mab infusion 400 ug/kg Day - 4 CD45 Mab infusion 400mg/kg Day - 3 CD45 Mab infusion 400 mg/kg Day - 2 CD45 Mab infusion 400 mg/kg Day - 1 Day 0 CTL infusion II (provided CD45 MAb <100)
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Any patient with EBV positive NPC, in relapse or with primary resistant disease - Life expectancy of more than 6 weeks. - No severe intercurrent infection - Patient, parent/guardian able to give informed consent - Bilirubin less than 2x normal - SGOT less than 3x normal, - Hgb higher than 8.0 g/L - Creatinine less than 2x normal for age - Patients should have been off other investigational therapy for one month prior to entry in this study. - Karnofsky score of over or equal to 50. Exclusion Criteria: - Patient, parent/guardian unable or unwilling to give informed consent - Patients with a Karnofsky score of < 50 - Patients with a severe intercurrent infection - Patients with a life expectancy of <6 weeks - Patients with a bilirubin of more than 2x normal. SGOT of more than 3x normal - Patients with a creatinine of more than 2x normal for age - Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
MalcolmBrenner, Study Chair, Baylor College of Medicine
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Helen Heslop 832-824-4662
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting HELEN HESLOP 832-824-4662
Additional Information:
Study ID Numbers: H14214; CLANC
Study Start Date: September 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078546
Other Nasopharyngeal Cancer Studies:
1. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
2. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
3. Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat
4. EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
5. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
Related Studies:
Other Nasopharyngeal Cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
EBV-Specific CTLs Following CD45 Antibody to Patients with Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
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