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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.
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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.
Study Period:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC vaccine | Experimental | Dendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT and Survivin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-006 vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events | 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. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine immunological response to the vaccine (induction of specific T-cell response) | 8, 12 weeks after start of vaccination and every 3 months thereafter | |
| Determine time of disease progression and survival time. | Clinical response will be evaluated via:
|
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Steinar Aamdal, M.D PhD Prof | Oslo University Hospital - Norwegian Radium Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital- Norwegian Radium Hospital | Oslo | 0424 | Norway |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Every 4 weeks during vaccination and every 3-6 months during follow up |
| Treatment free interval | Start date of new antineoplastic therapy since discontinuation of the study will be recorded to capture information regarding treatment free interval. | up to 5 years after vaccination |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |