Interferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II study
| ISRCTN | ISRCTN11978947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11978947 |
| ClinicalTrials.gov (NCT) | NCT00027664 |
| Protocol serial number | CO0.024 |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | Not provided at time of registration |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Interferon alpha, thalidomide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/01/2019: No publications found, verifying status with principal investigator
