Interferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II study
ISRCTN | ISRCTN11978947 |
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DOI | https://doi.org/10.1186/ISRCTN11978947 |
ClinicalTrials.gov number | NCT00027664 |
Secondary identifying numbers | CO0.024 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 25/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Interferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II study |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Interferon alpha, thalidomide |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/02/2001 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/02/2001 |
Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
https://ror.org/054225q67 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
25/01/2019: No publications found, verifying status with principal investigator