Condition category
Cancer
Date applied
15/07/2015
Date assigned
15/07/2015
Last edited
28/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr John Maher

ORCID ID

Contact details

Department of Research Oncology
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

201-20016-54

ClinicalTrials.gov number

Protocol/serial number

19183

Study information

Scientific title

Phase 1 trial: T4 immunotherapy of head and neck cancer

Acronym

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

NRES committee west London, 20/11/2012, ref: 12/LO/1834

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

05/06/2015

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

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

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

30/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Research Oncology, Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Jon Moulton Charitable Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The analysed results of the completed phase 1 trial will be published in a peer reviewed journal

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes