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Phase I/II Trial of Vaccine Therapy in Recurrent Platinum Sensitive Epithelial Ovarian Cancer Patients Using Autologous Dendritic Cells Loaded With Amplified Ovarian Cancer Stem Cell mRNA, hTERT and Survivin.

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

Thank you

Trial Information

Phase I/II Trial of Vaccine Therapy in Recurrent Platinum Sensitive Epithelial Ovarian Cancer Patients Using Autologous Dendritic Cells Loaded With Amplified Ovarian Cancer Stem Cell mRNA, hTERT and Survivin.

Study Period:

- Estimated date of first patient enrolled: First quarter of 2011

- Anticipated recruitment period: 3 years

- Estimated date of last patient completed: First quarter of 2017, follow up to 2022.

Treatment duration:

Patients will receive intradermal immunization once a week for 4 weeks followed by monthly
"vaccine boost" during the first year. Patients that show immunological response will
continue with vaccination every month the second and third year or as long as there is
vaccine available. The patients will have follow up for 5 years or until progression of
disease as evaluated by the investigator.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and severity of adverse events

Outcome Description:

Patients are coming every 4 weeks to the site during the 3 years vaccination period and every 6 months during the 5 years follow up period. Biochemistry and hematology results, vital signs and ECOG performance status will be measured at those timepoints during vaccination period.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Steinar Aamdal, M.D PhD Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital - Norwegian Radium Hospital


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

April 2011

Completion Date:

April 2022

Related Keywords:

  • Recurrent Epithelial Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial