Killer T cell Therapy for Nasopharyngeal Carcinoma

Phase 1

Completed

• Conditions: Epstein-Barr virus associated Nasopharyngeal Carcinoma; Cancer - Head and neck

• Registration Number: ACTRN12609000675224
• Lead Sponsor: The University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-07
• Study Completion: 2016-04-14
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age 15 years or above.
2. Geographically accessible for follow up
3. Informed consent (from patient, or patient and parent/guardian if aged < 16 years) Approved hospital interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without the use of an interpreter.
4. Eastern Cooperative Oncology Group performance status 0, 1, 2 or 3
5. Previously diagnosed with stage II, III or IV nasopharyngeal carcinoma (NPC)
6. Life expectancy of at least 3 months.

Exclusion Criteria

1. EBV negative tumour
2. Inability to identify an LMP/EBNA1 peptide to stimulate CTL cultures
3. Positive serology for human immunodeficiency virus (HIV)
4. Serology indicating active Hepititis B Virus (HBV) infection or carrier status for HBV (N.B. Positive serology for HBV indicating previous but cleared infection with HBV would not be an exclusion criteria.)
5. Serology indicating active Hepititis C Virus (HCV) infection
6. Significant non –malignant disease (e.g. severe cardiac or respiratory dysfunction)
7. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial
8. Prior cancers, except those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of < 5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix.
9. Currently receiving immunosuppressive therapy, including corticosteroids.
10. Pregnancy, or unwilling to use adequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Safety of adoptive transfer will be monitored by blood tests to check full blood cell counts, biochemistry and liver function. Vital signs will be monitored and any adverse events will be recorded and treatment provided if required. A quality of life questionnaire will also assist in monitoring the tolerability of the adoptive transfer.[Safety and tolerability will be assessed through monitoring the patient on the day of each adoptive transfer - every 2 weeks for up to six transfers.]

Secondary Outcome Measures

Name	Time	Method
Efficacy:Efficacy will be assessed via immunological and virological monitoring - using Enzyme-linked immunosorbent spot (ELISPOT), tetramer and intracellular cytokine staining methods to measure CTL function ex vivo, and measuring Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) levels in the blood using real time polymerase chain reaction (PCR) to detect the BALF5 gene. <br><br>Efficacy will also be assessed via clinical monitoring. Reduction of tumour burden will be assessed via clinical examination and magnetic resonance imaging (MRI) and/or computed tomography (CT) scans[Post adoptive immunotherapy monitoring will be done at baseline, prior to each adoptive transfer (every 2 weeks for six transfers) and monthly until six months after the first adoptive transfer. <br><br>Reduction of tumour burden will be assessed at baseline and follow up scans will occur at 1, 2, 3, 4 & 6 months from the time of initial adoptive transfer.]