Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00027664
Protocol/serial number
CO0.024
Study information
Scientific title
Interferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II study
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Metastatic renal cell carcinoma
Intervention
Two arms:
1. Interferon-alpha three times per week. The first three doses will be 4.5 miu, 4.5 miu, 9 mui, then 9 mui six times each fortnight, for 12 weeks initially, then for a further 12 weeks if stable disease or better. Then 12-weekly cycles until progression.
2. Interferon-alpha and thalidomide. Interferon as above. Thalidomide 200 mg per day orally to be taken at night at least 2 h after the evening meal.
Intervention type
Drug
Phase
Phase II
Drug names
Interferon alpha, thalidomide
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2001
Overall trial end date
01/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Measurable progressive disease (greater than 1 cm non-irradiated marker lesions)
2. Calculated creatinine clearance greater than 60 ml/min or ethylene diamine tetra-acetic acid (EDTA) clearance greater than 40 ml/min
3. Normal bilirubin
4. Liver enzymes less than 5 x upper limit of normal range
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2001
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list