drugset / Trial / NCT01312389
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-05
- Completion
- 2012-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxidized tumor Cell Lysate | Vaccine | — | Intrathecal |
| Subject | Rintatolimod | Oligonucleotide (other) | 200 mg | Intravenous |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Intrathecal |