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
