A randomised controlled trial of Interferon-alpha (IFN-alpha), Interleukin-2 (IL-2) and 5 Fluorourcil (5-FU) versus Interferon-alpha alone in patients with advanced renal cell carcinoma

Not Applicable

Completed

• Conditions: Renal Cancer; Cancer; Renal cell carcinoma

• Registration Number: ISRCTN46518965
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

2005 rationale and progress in: http://www.ncbi.nlm.nih.gov/pubmed/16097560 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20153039

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-11-08
• Study Completion: 2006-07-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Histologically proven renal cell carcinoma. Material may be obtained from the primary tumour or the metastases
2. Advanced metastatic disease ? that, in the opinion of the investigator, requires treatment. (We would recommend that patients have undergone resection of their primary tumour prior to entry into the trial but this is not mandatory)
3. At least one measurable lesion. Measurements must be taken within the 4 week period before the start of treatment (single bone lesions should not be included due to assessing response)
4. WHO performance status 0 or 1
5. Normal haematological parameters (WBC >3 x 109/l; platelets >100 x 109/l; haemoglobin >10g/dl). This assessment should be carried out within 7 days before randomisation
6. Creatinine levels must be within normal limits for institution. If creatinine raised, then EDTA or creatinine clearance should be greater than 60ml/min
7. Life expectancy greater than 12 weeks
8. Written informed consent
9. Male or female patient of any ethnic group more than 18 years in age

Exclusion Criteria

1. No radiotherapy to target lesions during trial therapy
2. Previous chemotherapy, endocrine therapy or treatment with biological agents
3. No current or previous brain metastasis
4. Unstable angina pectoris or recent (6 month) myocardial infarction
5. Evidence of active infections requiring antibiotic therapy
6. Patients with major organ allografts (IL-2 may increase T-cell mediated rejection and immunosuppressive agents are likely to reduce efficacy of IL-2 and IFN-alpha
7. Patients who require or are likely to require corticosteroids for intercurrent disease
8. Pregnant or lactating women
9. Other disease or previous malignancy likely to interfere with the protocol treatments or comparisons
10. Patients with concurrent malignancy, unless they have remained free of the disease attributed to the malignancy for more than 5 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified