Safety and Biological Activity of TroVax® Vaccine Given With IL-2 in Renal Cell Carcinoma

Inclusion Criteria:

1. Locally advanced or metastatic, histologically proven clear cell or papillary cell renal carcinoma.
2. Primary tumour surgically removed.
3. Progressive disease
4. At least four weeks from any previous therapy for renal cancer.
5. Fit for first or second line immunotherapy with subcutaneous low dose IL-2
6. Measurable disease
7. Aged 18 years or more.
8. Patients must comply with the following:

   * Karnofsky score ≥ 80%
   * Corrected calcium ≥ 10 g/dL (2.5 mmols/L)
9. Clinically immunocompetent
10. Free of clinically apparent autoimmune disease.
11. Haemoglobin ≥ 9 g/dL, total white cell count ≥ 3 x 10\^9/L and lymphocyte count ≥ 1 x 10\^9/dL
12. Serum creatinine up to 1.5 times upper limit of normal.
13. Bilirubin ≤ 2 mg% and an SGPT of ≤ 4 times the upper limit of normal.
14. Able to give written informed consent and to comply with the protocol.
15. Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception while they are being treated with TroVax®.
16. No acute changes on 12-lead electrocardiogram (ECG)
17. Ejection fraction on echocardiogram ≥ 45%

Exclusion Criteria:

1. Previous immunotherapy with any schedule of IL-2.
2. Intercurrent serious infections within the 28 days prior to entry into the trial.
3. Life threatening illness unrelated to cancer.
4. Cerebral metastases on MRI scan.
5. History of allergic response to previous vaccinia vaccinations.
6. Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial.
7. Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
8. Previous history of major psychiatric disorder requiring hospitalisation or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
9. Known allergy to egg proteins
10. Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
11. Known to test positive for HIV or hepatitis B or C
12. Known hypersensitivity to neomycin
13. Pregnancy or lactation