A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer

Inclusion Criteria:

* Metastatic renal clear cell adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis. If a fresh specimen is obtained for diagnostic purposes, it may be frozen and stained for 5T4. Prior nephrectomy is not required.
* Requiring treatment with IL-2 and able to tolerate a high dose schedule per institutional standards.
* Aged 18 years or more.
* Performance status (ECOG) 0 or 1.
* Expected survival longer than three months.
* No clinically active autoimmune disease.
* Total white cell count greater than or equal to 3 x 109/l.
* Platelet count greater than or equal to 90,000/mm3.
* Serum creatinine 1.6 mg/dl or less.
* Total bilirubin 1.6 mg/dl or less.
* Serum AST/ALT greater than or equal to three times the upper limit of normal or 5 times upper limit of normal if liver metastases are present.
* Able to give written informed consent and to comply with the protocol.
* Women must be either post menopausal, rendered surgically sterile or practising a reliable form of contraception (hormonal, intrauterine device or barrier). Men must practise an effective form of birth control, such as barrier protection.
* Normal cardiac stress test if the patients are older than 50 years of age or have symptoms of cardiac disease.
* Normal pulmonary function tests if the patient is a smoker or is known to have primary lung disease.

Exclusion Criteria:

* Pregnancy, lactation or lack of effective contraception in fertile men and women of childbearing potential.
* Intercurrent serious infections within the 28 days prior to entry to the trial.
* Known to be HIV positive because HIV infection can lead to serious adverse events with vaccination and/or high-dose IL-2.
* Life threatening illness unrelated to cancer.
* Cerebral metastases.
* History of allergic response to previous vaccinia vaccinations.
* Participation in any other clinical trial within the previous 30 days .
* Previous malignancies within the last two years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
* 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.
* Corticosteroids unless used as an antiemetic.
* Family contact with active eczema, exfoliative skin disorder, pregnancy or other cause of immunocompromise.