T4 immunotherapy of head and neck cancer
| ISRCTN | ISRCTN81726461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81726461 |
| EudraCT/CTIS number | 2012-001654-25 |
| ClinicalTrials.gov number | NCT01818323 |
| Secondary identifying numbers | 19183 |
- Submission date
- 15/07/2015
- Registration date
- 15/07/2015
- Last edited
- 04/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Dr John Maher
Public
Public
Department of Research Oncology
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Phase 1 trial: T4 immunotherapy of head and neck cancer |
| Study hypothesis | Intra-tumoural delivery of T4 immunotherapy will provide a safe and efficacious immunotherapy for locally advanced / recurrent squamous cell carcinoma of head and neck. |
| Ethics approval(s) | NRES committee west London, 20/11/2012, ref: 12/LO/1834 |
| Condition | Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck |
| Intervention | Intratumoural T4 immunotherapy, delivered at a single setting to multiple points in a locally advanced or recurrent tumour. Study Entry : Registration only |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | T4 |
| Primary outcome measure | To define dose limiting toxicities for T4 immunotherapy in SCCHN. |
| Secondary outcome measures | 1. To determine a safe and feasible recommended dose for phase II testing of intra-tumoural T4 Immunotherapy 2. To investigate serum cytokine levels after administration of T4 immunotherapy 3. To investigate persistence of T4+ T-cells at the site of administration and in the peripheral circulation 4. To achieve preliminary assessment of anti-tumour activity, using cross-sectional imaging to quantify objective responses 5. To investigate tumour ErbB receptor phenotype, before and after administration of T4 immunotherapy 6. To investigate immunomodulatory effects of low dose cyclophosphamide on T4 immunotherapy. 7. To investigate effect of T4 immunotherapy upon immune reactivity against endogenous tumour antigens |
| Overall study start date | 05/06/2015 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 21; UK Sample Size: 21; Description: Six cohorts of 3 patients each plus one expansion cohort of 3 patients |
| Total final enrolment | 25 |
| Participant inclusion criteria | 1. Histologically and/ or cytologically confirmed SCCHN 2. 18 years or older 3. Locally advanced and/ or recurrent head and neck cancer with or without metastatic disease (excluding brain metastases) for whom no standard therapy remains or is suitable 4. Regarding previous treatment, patients may have received prior systemic therapy, including platinum chemotherapy, at least one month earlier. In the presence of metastatic disease, recent short-course palliative radiotherapy to non-target site(s) is allowed 5. Those who refuse palliative treatment may be eligible for participation. However, their reasons for not opting for palliative treatment must be explored thoroughly 6. At least one loco-regional target lesion measurable by RECIST v1.1 criteria on CT or MRI scanning within four weeks of enrolment, and amenable to intra-tumoral injection 7. Eastern Co-operative Oncology Performance Status of 0-2 8. Normal cardiac function as assessed by electrocardiography and either echocardiography (ECHO), or multi-gated aquisition (MUGA) scanning. Left ventricular ejection fraction must be >50%. Assessment must take place within four weeks of enrolment 9. Haematology results within seven days of enrolment: neutrophilis >1.5 x 109/L, platelets >100 x 109/L, haemoglobin >9g/dl, INR <1.5 10. Biochemistry results within seven days of enrolment: 10.1. Serum creatinine <1.5 upper limit of normal 10.2. Bilirubin <1.25 times normal 10.3. ALT/ AST <2.5 times upper limit of normal (<5 times upper limit of normal if liver metastases present) 11. Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception. Women of childbearing potential (WOCB) who receive cyclophosphamide must adhere to these contraceptive requirements during the trial and until 3 months after the last dose of cyclophosphamide. Male patients, even if sterlized, must agree to use a barrier method of contraception. Male subjects must also commit to use a barrier method of contraception until at least 3 months after the end of study treatment 12. Written informed consent prior to registration |
| Participant exclusion criteria | 1. The presence of or imminent occurrence of airway obstruction, unless tracheostomy in place 2. The presence of or imminent occurrence of tumour-mediated infiltration of major blood vessels 3. Positive history of HIV-1, HIV-2, HTLV-1, HTLV-2, Hepatitis B, Hepatitis C or syphilis infection. 4. Prior splenectomy 5. Clinically active autoimmune disease. Sub-clinical or quiescent autoimmune disease does not exclude from participation 6. Treatment in the preceding week with systemic corticosteroids (> 20mg prednisolone/ day), any systemic immunomodulatory agent, radiotherapy, chemotherapy or investigational medicinal product 7. Concurrent use of anticoagulant therapy is not permissible 8. The presence of major co-morbidity likely to impair ability to undergo trial therapy, such as recent myocardial infraction, congestive cardiac failure or uncontrolled hypertension 9. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 10. Cyclophosphamide allergy - Final (sixth) cohort only 11. Pregnancy 12. Prior T4 immunotherapy |
| Recruitment start date | 05/06/2015 |
| Recruitment end date | 15/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Research Oncology, Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
London
SE1 9RT
United Kingdom
Sponsor information
King's College London
University/education
University/education
Strand
London
WC2R 2LS
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Government
Jon Moulton Charitable Foundation
No information available
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The analysed results of the completed phase 1 trial will be published in a peer-reviewed journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 15/06/2023 | 12/12/2023 | Yes | No | |
| Protocol file | version 2.5 | 31/05/2015 | 12/12/2023 | No | No |
Additional files
Editorial Notes
04/12/2024: The following changes were made:
1. The recruitment end date was changed from 30/09/2017 to 15/10/2024.
2. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
12/12/2023: The following changes have been made:
1. Protocol file (not peer reviewed) uploaded.
2. Publication reference added.
3. ClinicalTrials.gov number added.
4. The overall study end date was changed from 31/12/2023 to 31/12/2024.
5. The EudraCT/CTIS number was updated.
01/11/2023: The study contact confirmed that no changes were required to the study record at that time.
01/04/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/04/2021 to 31/12/2023.
2. The intention to publish date has been changed from 31/12/2021 to 31/12/2024.
3. The total final enrolment number has been added.
03/04/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/04/2019 to 01/04/2021.
2. The intention to publish date was added.
05/03/2019: Internal review.
03/10/2018: The overall trial end date has been changed from 30/09/2017 to 01/04/2019.
