NASOPHARYNGEAL CARCINOMA Clinical Trial
— DELLAOfficial title:
Administration of LMP1- and LMP2-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody Administration to Patients With EBV-Positive Nasopharyngeal Carcinoma
Verified date | April 2012 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
In this study NPC patient will receive 4 days of treatment with CD45 antibody followed by
one dose of LMP1- and LMP2-CTL. From this, we can learn if treating the patient first with
the CD45 antibody will also let LMP1- and LMP2-CTL we give grow better. In addition, we will
find out, if LMP1- and LMP2-CTL are safe and have enhanced anti-tumor activity in comparison
to standard EBV-CTL.
This study aims to determine the safety of autologous LMP1- and LMP2- specific cytotoxic
T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with
EBV-positive nasopharyngeal carcinoma (NPC).
And to obtain information on the expansion, persistence and anti-tumor effects of autologous
LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with
EBV-positive NPC.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: All patients with NPC in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive) in whom the EBV genome or antigens have been demonstrated in tissue biopsies will be eligible for this trial. Any patient with EBV positive NPC, in relapse or with primary resistant disease Patients with a life expectancy 6 weeks or greater. Patients with a Karnofsky score (age at least 16; for Karnofsky scale see full protocol) or Lansky score (less than 16; for Lansky scale see full protocol) of 50 or greater as described below: Patients with bilirubin <2x normal, SGOT <3x normal, and Hgb greater than 8.0. Patients with a creatinine 2x normal or less for age. Patients should have been off other investigational therapy for one month prior to entry in this study. Patient, parent/guardian able to give informed consent. Exclusion Criteria: Severe intercurrent infection. 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 investigatorĀ”-s discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, The Methodist Hospital System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety of autologous LMP1- and LMP2- specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with EBV-positive nasopharyngeal carcinoma (NPC). | 12 months | Yes | |
Secondary | To obtain information on the expansion, persistence and anti-tumor effects of autologous LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with EBV-positive NPC. | 12 months | Yes |
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