A phase III randomised, double-blind trial of immunotherapy with a polyvalent melanoma vaccine (C-VAX) plus bacille Calmette-Guerin (BCG) versus placebo plus BCG as a post surgical treatment for stage IV melanoma
| ISRCTN | ISRCTN72807124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72807124 |
| Secondary identifying numbers | N0436044028 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 PM Patel
Scientific
Scientific
Medical Oncology
Cancer Studies
ICRF Research Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A phase III randomised, double-blind trial of immunotherapy with a polyvalent melanoma vaccine (C-VAX) plus bacille Calmette-Guerin (BCG) versus placebo plus BCG as a post surgical treatment for stage IV melanoma |
| Study objectives | To establish whether adjuvant C-VAX plus BCG will prolong disease free and overall survival compared to placebo plus BCG in stage IV melanoma patients who have no evidence of disease post-surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Stage IV melanoma |
| Intervention | Randomised controlled trial. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | C-VAX, BCG |
| Primary outcome measure | Progression free survival. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/1999 |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with resected stage IV melanoma. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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
05/03/2019: Internal review.
