A clinical trial of adoptive T-cell immunotherapy for patients with Epstein-Barr virus-associated nasopharyngeal carcinoma.

Phase 1

• Conditions: Metastatic nasopharyngeal carcinoma; Cancer - Head and neck

• Registration Number: ACTRN12613000866707
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-06
• Study Completion: 2021-04-29
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Age 18 years or above
2 . Histologically proven NPC (non-keratinising or undifferentiated carcinoma) at first diagnosis
3. Provision of Informed consent. 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. First relapse of NPC; either metastatic disease or loco-regionally recurrence that is not resectable
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
6. Life expectancy of at least 6 months, as determined by the clinical investigator
7. Adequate haematological and biochemical function
8. Completion of a medical questionnaire
9. Suitable to commence treatment, or currently receiving treatment , for metastatic disease or recurrent loco-regional disease not amenable to surgery

Exclusion Criteria

1. EBV negative tumour
2 . Serological evidence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis infection (N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion)
3. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction)
4.. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial
5. Inability to provide informed consent, including patients with severe cognitive impairment, intellectual disability or mental illness
6. Prior cancers, except those diagnosed greater than 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5 percent, or successfully treated nonmelanoma skin cancer, or carcinoma in situ of the cervix.
7. Currently receiving immunosuppressive therapy, including corticosteroids. At the discretion of the clinical investigator the patient can receive anti-emetics
8. Pregnant, lactating, or unwilling to use adequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified