An international, randomised, double-blind, placebo-controlled, parallel group study to investigate whether a minimum of three doses of TroVax®, added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma

Not Applicable

Completed

• Conditions: ocally advanced or metastatic clear cell renal adenocarcinoma; Cancer; Locally advanced or metastatic clear cell renal adenocarcinoma

• Registration Number: ISRCTN39198692
• Lead Sponsor: Oxford BioMedica

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20881001 (added 26/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-18
• Study Completion: 2009-09-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements.
2. Locally advanced or metastatic, histologically proven clear cell renal carcinoma
3. Primary tumour surgically removed (some residual advanced primary tumour may remain)
4. At least four weeks post surgery or radiotherapy
5. First-line. No prior therapy for renal cancer except surgery or radiotherapy
6. Measurable disease
7. Aged 18 years or more
8. Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the investigator there is a >90% probability that the patient will survive >12 weeks if treated with the selected standard of care)
9. Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including systemic lupus erythematosis, Grave?s disease, Hashimoto?s thyroiditis, multiple sclerosis, insulin-dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease)
10. Total white cell count =3 x 10^9 /l and lymphocyte count =1 x 10^9 /l
11. Serum creatinine =1.5 times the upper limit of normal
12. Bilirubin =2 times the upper limit of normal and a serum glutamic pyruvic transaminase (SGPT) of =4 times the upper limit of normal
13. 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 and 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 (barrier or vasectomy) while they are being treated with TroVax®.
14. No acute changes on 12-lead electrocardiogram (ECG)
15. Ejection fraction documented as not less than 45% or no clinical suspicion that cardiac ejection fraction is less than 45%. (If clinical suspicion exists the ejection fraction should be measured according to local site procedures).

Exclusion Criteria

1. Cerebral metastases. (Known from previous investigations or clinically detectable)
2. Previous exposure to TroVax®
3. Serious infections within the 28 days prior to entry to the trial
4. Known to test positive for human immunodeficiency virus (HIV) or hepatitis B or C
5. Life threatening illness unrelated to cancer
6. History of allergic response to previous vaccine vaccinations
7. Known allergy to egg proteins
8. Known hypersensitivity to neomycin
9. Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial
10. 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
11. Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient?s ability to provide informed consent or to comply with the protocol
12. Oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency
13. Ongoing use of agents listed in locally approved prescribing information as causing immunosuppression
14. Prior history of organ transplantation
15. Pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified