A preliminary study of the safety, immunogenicity and clinical efficacy of TroVax® given in conjunction with interleukin 2 (IL-2) in the treatment of stage IV renal cell cancer

Phase 1

Completed

• Conditions: Renal cancer; Cancer; Malignant neoplasm of kidney, except renal pelvis

• Registration Number: ISRCTN83977250
• Lead Sponsor: Oxford BioMedica (UK)

Brief Summary

1. 2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19128501 (added 01/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-07-11
• Study Start: 2008-11-10
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Both males and females, aged 18 years or more
2. 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.
3. Requiring treatment with IL-2 and able to tolerate a high dose schedule per institutional standards
4. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1
5. Expected survival longer than three months
6. No clinically active autoimmune disease
7. Total white cell count ?d 3 x 10^9/l
8. Platelet count ?d 90,000/mm^3
9. Serum creatinine 1.6 mg/dl or less
10. Total bilirubin 1.6 mg/dl or less
11. Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ?T three times the upper limit of normal or 5 times upper limit of normal if liver metastases are present
12. Able to give written informed consent and to comply with the protocol
13. 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.
14. Normal cardiac stress test if the patients are older than 50 years of age or have symptoms of cardiac disease
15. Normal pulmonary function tests if the patient is a smoker or is known to have primary lung disease

Exclusion Criteria

1. Pregnancy, lactation or lack of effective contraception in fertile men and women of childbearing potential
2. Intercurrent serious infections within the 28 days prior to entry to the trial
3. Known to be HIV positive because HIV infection can lead to serious adverse events with vaccination and/or high-dose IL-2
4. Life threatening illness unrelated to cancer
5. Cerebral metastases
6. History of allergic response to previous vaccinia vaccinations
7. Participation in any other clinical trial within the previous 30 days
8. 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
9. 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
10. Corticosteroids unless used as an antiemetic
11. Family contact with active eczema, exfoliative skin disorder, pregnancy or other cause of immunocompromise

Study & Design

• Study Type: Interventional
• Study Design: Not specified