Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients

This is an interventional treatment trial for Recurrent Epithelial Ovarian Cancer Read More

Inclusion Criteria:

• Histologically confirmed epithelial ovarian cancer. Histologic documentation of the original primary tumor is required via pathology report.
• Completed first line treatment (surgery and adjuvant or neoadjuvant treatment with carboplatine and paclitaxel)
• Relapsed and platinum sensitive epithelial ovarian carcinoma patients with response to chemotherapy in recurrent disease
• If surgery is indicated, the patient should be surgically treated and then starts vaccination with a minimum interval of 28 days.
• Must be ambulatory with an ECOG performance status 0 or 1.
• Life expectancy ≥ 6 months
• Must be of 18-75 years of age

• Must have lab values as the following:

  • ANC ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hb ≥ 9 g/dL (≥ 5.6 mmol/L)
  • Creatinine ≤ 140 μmol/L (1.6 mg/dL); if borderline, the creatinine clearance ≥ 40 mL/min
  • Bilirubin within the upper limit of normal
  • ASAT and ALAT ≤ 2.5 the upper limit of normal
  • Albumin levels above lower normal value
• If the patient has preserved fertility after primary treatment, she must practice adequate contraception during the study treatment
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

• Eligible to otherwise curative treatment.
• History of prior malignancy, other than ovarian cancer, within the last 5 years, with the exception of curatively treated basal cell carcinoma and cancer in situ cervix uteri.
• Prior surgery within the past 28 days
• Clinical ascites or metastatic pleural fluid
• Active infection requiring antibiotic therapy.
• Have known active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis). Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis.
• Significant cardiac or other medical or mental illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, serious cardiac arrhythmia or psychosis.
• Pregnancy or lactation
• Previous adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
• History of immunodeficiency or autoimmune disease such as but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
• Positive for syphilis (treponema pallidum), HIV, Hepatitis B and C tests
• Use of systemic glucocorticoids.
• Prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents stopped for less than 4 weeks before first study treatment administration. Anti hormonal treatment, such as Tamoxifen, may continue until first study treatment administration.
• Any reason why, in the opinion of the investigator, the patient should not participate.