Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GM-CSF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| CEA DNA prime (cohort I) | EXPERIMENTAL | 5 patients, tetwtCEA DNA intradermal delivery with electroporation, not previously vaccinated with CEA66 DNA. Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration. One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA. |
| CEA DNA boost (cohort II) | EXPERIMENTAL | 10 patients, tetwtCEA DNA intradermal delivery with electroporation, previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA. |
| CEA DNA prime + GM-CSF (cohort III) | EXPERIMENTAL | 5 patients, tetwtCEA DNA intradermal delivery with electroporation + GM-CSF, not previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA. |
| Name | Type | Description |
|---|---|---|
| tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope) | BIOLOGICAL | Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation |
| Derma Vax (electroporation device) | DEVICE | Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration |
| GM-CSF | BIOLOGICAL | GM-CSF will be given for 4 consecutive days starting the day before the vaccination as an intradermal/subcutaneous administration of 150 ug of GM-CSF |
| Cyclophosphamide | DRUG | One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA |
Inclusion Criteria: * Histological confirmed AJCC stage II or III colorectal cancer * Resection of the primary tumour without evidence of remaining macroscopic disease * Allowable standard chemotherapy or radiotherapy in AJCC stage III completed minimum 2 months prior study entry * Patients recruit...
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