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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Recurrent Ovarian Cancer

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Trial Information

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.

Inclusion Criteria:

- Histological proven epithelial ovarian cancer, peritoneal cavity or fallopian tube
cancer (inclusive mucinous or clear cell tumors)

- Tumor over-expressing p53

- Progression of disease or relapse after previous therapy with platinum

- Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper limit of normal
within 3 months and confirmed

- Age ≥ 18 years

- WHO performance status 0-2

- Adequate bone marrow function: WBC ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l,
platelets ≥ 100 x 109/l

- Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (UNL) range, ALAT
and/or ASAT ≤ 2.5 x UNL, Alkaline Phosphatase ≤5 x UNL

- Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min

- Survival expectation > 3 months

- Patients must be accessible for treatment and follow-up

- Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

- Previous malignancy within 5 years, with exception of a history of a previous basal
cell carcinoma of the skin or pre-invasive carcinoma of the cervix.

- Serious other diseases as recent myocardial infarction, clinical signs of cardiac
failure or clinically significant arrhythmias

- Known hypersensitivity reaction to any of the components of the treatment

- Pregnancy or lactating

- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility (change in grade III and IV toxicity) and change in immunogenicity of the triple combination of gemcitabine, Peg-Intron and p53 SLP vaccination

Outcome Description:

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.

Outcome Time Frame:

Before treatment, after 2 months and after 6 months after start therapy

Safety Issue:


Principal Investigator

Judith R Kroep, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Leiden University Medical Center


Netherlands: Ministry of Health, Welfare and Sport

Study ID:

CHIP trial



Start Date:

August 2011

Completion Date:

Related Keywords:

  • Recurrent Ovarian Cancer
  • p53 overexpression
  • platinum-resistant
  • Ovarian Neoplasms