Recurrent Epithelial Ovarian CancerPhase 1/2NCT01334047
Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients
A Phase 1/2 study testing DC-006 vaccine in people with Recurrent Epithelial Ovarian Cancer, run by Steinar Aamdal at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Epithelial Ovarian Cancer
- What is being tested?
- DC-006 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Recurrent Epithelial Ovarian Cancer
- Being tested
- DC-006 vaccine
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-006 vaccineBiological
Also called Dendritic cell 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.
| Study group | Role | What they receive |
|---|---|---|
| DC vaccine | Experimental | Dendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT and Survivin. Receives: Biological: DC-006 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (3)
Determine immunological response to the vaccine (induction of specific T-cell response)
Measured: 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:
- 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.
Measured: 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.
Measured: up to 5 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steinar Aamdal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steinar Aamdal, Oslo University Hospital
- Investigators
- Steinar Aamdal, M.D PhD Prof, Principal investigator, Oslo University Hospital - Norwegian Radium Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334047
- Sponsor's protocol ID
- DC-006
- Status last verified
- Feb 2021
- First submitted
- 30 Mar 2011
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01334047
- Acronym / sponsor ID
- DC-006
- Conditions
- Recurrent Epithelial Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Steinar AamdalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC vaccine | Experimental | Biological: DC-006 vaccineDendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT and Survivin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC-006 vaccineAlso: Dendritic cell vaccineVaccine 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. | Biological | DC vaccine |
Primary outcome
Frequency and severity of adverse events
Time frame: Up to 3 years
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.
3 secondary outcomes
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
Determine time of disease progression and survival time.
Time frame: Every 4 weeks during vaccination and every 3-6 months during follow up
Treatment free interval
Time frame: up to 5 years after vaccination
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steinar Aamdal, M.D PhD Prof principal investigator
Oslo University Hospital - Norwegian Radium Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DC-006 vaccine in people with Recurrent Epithelial Ovarian Cancer, run by Steinar Aamdal at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.