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Phase I Trial: T4 Immunotherapy of Head and Neck Cancer

Phase 1
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

Phase I Trial: T4 Immunotherapy of Head and Neck Cancer

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

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 acquisition (MUGA) scanning. Left ventricular
ejection fraction must be > 50%. Assessment must take place within four weeks of

9. Haematology results within seven days of enrolment: neutrophils >1.5 x 109/L,
platelets >100 x 109/L, haemoglobin >9g/dl, INR <1.5.

10. Biochemistry results within seven days of enrolment: • serum creatinine <1.5 upper
limit of normal • bilirubin <1.25 times normal; • 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 sterilized, 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.

Exclusion Criteria:

1. The presence of or imminent occurrence of airway obstruction, unless tracheostomy in

2. The presence of or imminent occurrence of tumour-mediated infiltration of major blood

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 infarction, congestive cardiac failure or uncontrolled

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 (Cohort 6 only).

11. Pregnancy.

12. Breastfeeding.

13. Prior T4 immunotherapy.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Dose limiting toxicities for T4 immunotherapy in SCCHN and determine a safe and feasible recommended dose for phase II testing of intra-tumoral T4 immunotherapy.

Outcome Description:

Patients will be monitored intensely for the first 24 hours post T4 administration. Patients will the be assessed for signs of toxicity on days 3-4, 5-7, 8, 15, 29 and 43.

Outcome Time Frame:

Up to 6 weeks post T4 administration

Safety Issue:


Principal Investigator

John Maher, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College London


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2013

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Chimeric antigen receptor
  • Immunotherapy
  • Head and Neck Cancer
  • Phase I trial
  • Maximum tolerated dose
  • Head and Neck Neoplasms