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Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients

This study has been terminated.
(The study needed to be terminated due to new knowledge about cancer vaccines. A new protocol with an expected more efficient vaccine is currently being written.)
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01334047
First received: March 30, 2011
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

In this study the investigators will include patients with relapsed epithelial ovarian cancer. In spite of increased rates of complete response to initial chemotherapy, most patients with advanced ovarian cancer relapse and succumb to progressive disease. Immunotherapy may have potential for consolidation therapy. Dendritic cell vaccine is well toleranted in previous studies, with minor side effects and no serious adverse events registrated In this study, patients will receive DC-vaccine therapy after response to platinum treatment at relapse. The investigtors include patients in good clinical condition with no severe symptoms of the disease. If patients relapse during vaccine treatment, they will be discontinued from the study.

The investigators have included hTERT- and survivin mRNA in addition to amplified cancer stem cell mRNA in the vaccine.


Condition Intervention Phase
Recurrent Epithelial Ovarian Cancer
Biological: DC-006 vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Determine immunological response to the vaccine (induction of specific T-cell response) [ Time Frame: 8, 12 weeks after start of vaccination and every 3 months thereafter ] [ Designated as safety issue: No ]
  • Determine time of disease progression and survival time. [ Time Frame: Every 4 weeks during vaccination and every 3-6 months during follow up ] [ Designated as safety issue: No ]

    Clinical response will be evaluated via:

    • measurement of CA-125 every 4 weeks
    • physical examination every 3rd months during vaccination
    • CT taken every 3rd months during vaccinaton and every 3-6 months during follow up.

  • Treatment free interval [ Time Frame: up to 5 years after vaccination ] [ Designated as safety issue: No ]
    Start date of new antineoplastic therapy since discontinuation of the study will be recorded to capture information regarding treatment free interval.


Enrollment: 5
Study Start Date: April 2011
Estimated Study Completion Date: April 2022
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DC vaccine
Dendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT and Survivin.
Biological: DC-006 vaccine
Vaccine is administered every 4 weeks during the first year. Only patients that show immunological response will continue vaccination every months during the 2nd and 3rd year.
Other Name: Dendritic cell vaccine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334047

Locations
Norway
Oslo University Hospital- Norwegian Radium Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Steinar Aamdal, M.D PhD Prof Oslo University Hospital - Norwegian Radium Hospital
  More Information

No publications provided

Responsible Party: Prof. Steinar AAmdal, Oslo University Hospital- Norwegian Radium Hospital
ClinicalTrials.gov Identifier: NCT01334047     History of Changes
Other Study ID Numbers: DC-006
Study First Received: March 30, 2011
Last Updated: August 22, 2014
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014