| Source of record | UK Trials |
| ISRCTN | ISRCTN11978947 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | CO0.024 |
| Public title | Interferon Alpha in Combination with Thalidomide in the Treatment of Metastatic Renal Cell Carcinoma - a Randomised Phase II Study |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Kidney |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Measurable progressive disease (>1 cm non-irradiated marker lesions)
2. Calculated creatinine clearance >60 ml/min or Ethylene Diamine Tetraacetic Acid (EDTA) clearance >40ml/min
3. Normal bilirubin
4. Liver enzymes < 5x upper limit of normal range |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/02/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN11978947 |
| Date last extracted from ISRCTN register | 17/04/2008 |
