Chemo-Immunotherapy, Gemcitabine With Pegylated Interferon Alpha-2b (Peg-Intron) With and Without p53 Synthetic Long Peptide (p53 SLP) Vaccine, for Patients With Platinum Resistant Ovarian Cancer CHIP Trial
Recurrent ovarian cancer has a dismal prognosis and there is a pressing need to identify
more efficient therapies. Ovarian cancer is highly immunogenic and good survival is tightly
linked to the presence of tumor-infiltrating T cells and the absence of immunosuppressive
immune cells. This anti-tumor immune response might be primed by chemotherapy.
Gemcitabine has immune-modulatory properties in addition to its direct cytotoxic effect in
platinum resistant ovarian cancer. Additionally, Peg-Intron allows the full maturation of
dendritic cells, thereby enhancing the anti-tumor response. Moreover, the tumor-associated
self-antigen p53 is commonly over-expressed in ovarian cancer and can serve as a target for
immunotherapy. Therefore, chemo-immunotherapy with gemcitabine and Peg-Intron plus/minus p53
SLP vaccination seems an attractive treatment for recurrent, p53+ ovarian cancer patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility (change in grade III and IV toxicity) and change in immunogenicity of the triple combination of gemcitabine, Peg-Intron and p53 SLP vaccination
During the trial we will measure the incidence and severity of all side effects (according to CTC version 4.0). The change in immunogenecity will be measured according to the induction of p53-specific T cells upon treatment.
Before treatment, after 2 months and after 6 months after start therapy
Judith R Kroep, MD, PhD
Leiden University Medical Center
Netherlands: Ministry of Health, Welfare and Sport