Phase I/II trial of vaccine therapy in patients with recurrent ovarian cancer.
- Conditions
- Relapsed and platinum resistant epithelial ovarian carcinoma patients that have received one line of non-platinum chemotherapy in resistance disease setting.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-020233-56-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 20
•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)
•Residual tumor =1 cm after primary surgery
•Relapsed and platinum resistant epithelial ovarian carcinoma patients that have received one line of non-platinum chemotherapy in resistance disease setting.
•Start of vaccine therapy within 4-6 weeks after end of last chemotherapy regimen.
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•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
•Symptoms of the recurrent disease that can be treated by chemotherapy.
•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 rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
•Positive for 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.
•Previous treatment with dacarbazin or temozolomide at any time prior to study entry
•Any reason why, in the opinion of the investigator, the patient should not participate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety and toxicity of vaccination with DCs transfected with amplified ovarian cancer stem cell mRNA, h-TERT mRNA and survivin mRNA in patients with relapsed and platinum resistant ovarian cancer.;Secondary Objective: The secondary objectives are:<br>•Determine immunological response to the vaccine (induction of specific T-cell response) and time of disease progession and survival time. <br>•Monitor clinical treatment response with clinical examination, CA-125 evaluation and CT scans every third month.<br>;Primary end point(s): The primary end-point of this study is: Safety and toxicity of the vaccination with mRNA transfected DCs in terms of occurrence of related adverse events, especially grade 3/4 adverse events assessed by reference to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE). <br><br>;Timepoint(s) of evaluation of this end point: Those endpoints are evaluated continously. Patients are coming every 4 weeks to the site during the 3 years vaccination period.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary end-points of this study are: <br>•Biochemistry and hematology results, vital signs and ECOG performance status. <br>•Evaluation of immunological responses in terms of SI = 2 or delta = 10.000 measured by the 3H-thymidine proliferation test.<br>•Evaluation of clinical responses in terms of time to disease progression, also slow progressive disease, and survival time measured from the time of study-enrolment. <br><br><br>;Timepoint(s) of evaluation of this end point: Biochemistry and hematology results, vital signs and ECOG performance status will be measured every 4 weeks.<br><br>Immune response will be measured 8 and 12 weeks after start of vaccination and every 3 months thereafter.<br><br>Clinical response will be evaluated via:<br>-measurement of CA-125 every 4 weeks<br>-physical examination every 3rd months<br>-CT taken every 3rd months<br>