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 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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleInterferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II study
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMetastatic renal cell carcinoma
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Interferon alpha, thalidomide
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2001
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/02/2001
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

25/01/2019: No publications found, verifying status with principal investigator