Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000191493
Ethics application status
Approved
Date submitted
26/03/2007
Date registered
3/04/2007
Date last updated
24/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I Trial of Adoptive Immunotherapy for Stage III and IV Nasopharyngeal Carcinoma
Scientific title
Phase I trial to assess the safety of adoptive transfer of cytotoxic T cells specific for Epstein Barr Virus (EBV) latent membrane proteins (LMP) in patients with Stage III and IV nasopharyngeal carcinoma
Secondary ID [1] 354 0
Queensland Institute of Medical Research (QIMR): QIMR P810
Universal Trial Number (UTN)
Trial acronym
QPNPC01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal Carcinoma 1709 0
Condition category
Condition code
Cancer 1802 1802 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Autologous latent membrane protein (LMP)-specific cytotoxic T lymphocytes (CTL) suspended in Albumex 4 and 10% Dimethyl Sulfoxide (DMSO). Between 20-200 x 106 LMP-CTL. Dose variation within this range will depend on the manufacture/availability of cytotoxic T cells specific for Epstein Barr Virus (EBV) latent membrane proteins (LMP) 1 1nd 2. CTL will be transferred intravenously, total volume no greater than 14 mls.

Duration of intervention: Autologous LMP-CTL will be transferred fortnightly, minimum of 3 and up to a total of 6 infusions will be performed. The number of infusions given to a trial subject (minimum of 3 and maximum of 6) will depend on the avilability of autologous LMP-CTL. The number of infusions will not increase if there were no changes within the immunological parameters. Trial treatment aims for 6 doses, but subjects, who complete 3 or more doses will be included in statistical analysis. Each infusion takes 30 to 45 minutes to administer. There is approximately two week interval between infusions.
Intervention code [1] 1667 0
Treatment: Other
Comparator / control treatment
Control: N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2522 0
Tolerability and Safety: Changes in a variety of immunological parameters correlated with clinical response to treatment.
Main immunological parameters and clinical response to treatment are:
-Measurements of latent membrane proteins (LMP)-specific Cytotoxic T lymphocyte (CTL) in ex vivo blood;
-Levels of Epstein Barr virus Deoxyribonucleic acid (EBV DNA);
-Phenotyping;
-Interferon-gamma (IFN-?) production in response to latent membrane proteins (LMP) peptide stimulation;
-Serum biochemistry;
-Liver function tests;
-Full blood count;
-Reported Adverse and Serious Adverse Events;
-Quality of life using Functional Assessment of Cancer Therapy, Head and Neck (FACT ?H&N) Quality of Life assessment questionnaire;
-Functional assessment using Easter Cooperative Oncology Group (ECOG) scale;
-Response Evaluation Criteria in Solid Tumours (RECIST), Clinical monitoring;
- reduction of tumour burden using MRI and or CT-scan;
-clinical examination.
In Hospital monitoring of vital signs including heart rate, O2 saturation, temperature, Blood Pressure and Respiration rate for a 24 hours period following adoptive transfer of CTL's.
Timepoint [1] 2522 0
Assessed at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 17, 21 and 25 weeks and then every 2 months until 24 months.
Secondary outcome [1] 4355 0
Efficacy: Changes in a variety of immunological parameters correlated with clinical response to treatment.
Timepoint [1] 4355 0
Assessed at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 17, 21 and 25 weeks and then every 2 months until 24 months.

Eligibility
Key inclusion criteria
1.Stage III or IV nasopharyngeal carcinoma as defined by the 6th edition of the UICC TNM staging. 2. Geographically accessible for follow up 3.Informed consent (from patient, or patient and parent/guardian if aged < 16 years) 4.ECOG performance status 1, 2 or 3 (see Appendix G). 5.Life expectancy of at least three months.
Minimum age
15 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:1.EBV negative tumour, as found in project P4902.Inability to identify a LMP peptide to stimulate CTL cultures3.Positive serology for HIV, 4.Serology indicating active HBV infection or carrier status for HBV 5.Serology indicating active HCV infection6.Significant non –malignant disease 7.Psychiatric, addictive or any condition which may compromise the ability to participate in this trial8.Prior cancers, except those diagnosed > five years ago with no evidence of disease recurrence and clinical expectation of recurrence <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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 1954 0
Charities/Societies/Foundations
Name [1] 1954 0
Queensland Cancer Fund
Country [1] 1954 0
Australia
Funding source category [2] 1955 0
Charities/Societies/Foundations
Name [2] 1955 0
Atlantic Philanthropies (Australia-based)
Country [2] 1955 0
Australia
Funding source category [3] 1956 0
Government body
Name [3] 1956 0
National Health and Medical Research Council
Country [3] 1956 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research
Address
300 Herston Rd, Herston 4006
Country
Australia
Secondary sponsor category [1] 1766 0
None
Name [1] 1766 0
N/A
Address [1] 1766 0
Country [1] 1766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3650 0
Queensland Institute of Medical Research
Ethics committee address [1] 3650 0
Ethics committee country [1] 3650 0
Australia
Date submitted for ethics approval [1] 3650 0
Approval date [1] 3650 0
10/11/2006
Ethics approval number [1] 3650 0
EC00278
Ethics committee name [2] 3651 0
Princess Alexandra Hospital
Ethics committee address [2] 3651 0
Ethics committee country [2] 3651 0
Australia
Date submitted for ethics approval [2] 3651 0
Approval date [2] 3651 0
13/12/2006
Ethics approval number [2] 3651 0
EC00167

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27770 0
Address 27770 0
Country 27770 0
Phone 27770 0
Fax 27770 0
Email 27770 0
Contact person for public queries
Name 10856 0
Ms Natasha Stevens
Address 10856 0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Postcode 4029
Country 10856 0
Australia
Phone 10856 0
61-7-33620412
Fax 10856 0
61-7-38453510
Email 10856 0
[email protected]
Contact person for scientific queries
Name 1784 0
Professor Dennis Moss
Address 1784 0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Country 1784 0
Australia
Phone 1784 0
07 33620347
Fax 1784 0
07 38453510
Email 1784 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.