Ovarian Epithelial CancerPhase 1NCT01456065
Safety of Active Immunotherapy in Subjects With Ovarian Cancer
A Phase 1 study testing Procure in people with Ovarian Epithelial Cancer, run by Life Research Technologies GmbH at 5 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the safety of the active immune therapy based on the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and Survivin-peptide double loaded DCs (Dendritic Cells) [Procure®] in patients with advanced ovarian cancer, enrolled into the study… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Epithelial Cancer
- What is being tested?
- Procure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2010to Apr 2013
- Phase
- Phase 1
- 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
- Patients with epithelial ovarian cancer FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) stage III in remission after treatment with surgery (hysterectomy and ovariectomy) and after the first primary chemotherapy (standard treatment e.g. 6-9x Carboplatin/Taxane)
- Age > 18 ≤ 75 years
- Histological confirmed FIGO stage III ovarian epithelial cancer
- Stable disease at screening visit: negative CT and CA-125 within normal range
- Karnofsky status ≥ 70% and/or ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Life expectancy ≥ 6 months
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- Adequate hematological function (WBC (white blood cells) ≥ 3000/µl, hemoglobin ≥ 10.0 g/dL, platelets > 100,000/µl)
- Adequate renal and hepatic function (serum creatinine ≤ 2.0 mg/dL, bilirubin total < 2 mg/dL, PT (INR) ≤ 1.5x institutional upper limit of normal)
- Signed and dated informed consent before the start of any study-specific procedure
- Body weight > 50 kg
Who cannot join
- Surgery, radiation therapy or chemotherapy within eight weeks prior to leukapheresis
- Other biological therapy (Interferons, TNF (Tumor necrosis factors), Interleukins, mABs (Monoclonal antibodies), biological response modifiers) within eight weeks prior to undergo the leukapheresis
- History or presence of systemic autoimmune disease (such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma or multiple sclerosis)
- Participation in other clinical trials or treatments with an investigational drug within four weeks prior to enrollment
- Serious intercurrent chronic or acute illness such as severe asthma or COPD (Chronic Obstructive Pulmonary Disease), cardiac (NYHA (New York Heart Association ) class III or IV) or hepatic disease, or other illness considered to constitute an unwarranted high risk for investigational drug treatment
- History of another malignancy within five years prior to study enrollment, except curatively treated non-melanotic skin cancer or cervical cancer in situ
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- Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or C
- Current treatment with corticosteroids (except of local) or other immunosuppressive agents such as azathioprine or cyclosporine A is excluded on the basis of its potential immune suppression. Any systemic steroid therapy must have been discontinued six weeks prior to undergo the leukapheresis
- Patients who have undergone organ transplantation
- Legally incapacitated persons and/or other circumstances, which make it difficult for the subject to understand the nature, meaning and consequences of the clinical study
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Austria3 sites
Hospital Landeskrankenhaus Innsbruck
Innsbruck, 6020
Hospital Korneuburg
Korneuburg, 2100
Hospital Barmherzigen Schwestern
Linz, 4010
Hungary2 sites
Semelweis University
Budapest, 1083
National Oncology Institute
Budapest, 1122
About this study
Official title: A Phase I, Open, Randomized, Study to Investigate the Safety of Active Immunotherapy With Fully Mature, TERT-mRNA and Survivin - Peptide Double Loaded Dendritic Cells (DCs) in Subjects With Advanced Epithelial Ovarian Cancer, Enrolled in the Study Within Twelve Weeks After Completing Primary Therapy
The purpose of this study is to investigate the safety of the active immune therapy based on the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and Survivin-peptide double loaded DCs (Dendritic Cells) [Procure®] in patients with advanced ovarian cancer, enrolled into the study within twelve weeks after completing primary therapy.
Read the detailed description
This is an uncontrolled, randomized, parallel-group, open-label phase I trial in patients with advanced epithelial ovarian cancer. Patients were randomized into treatment group A with weekly administration versus treatment group B with bi-weekly administration.
Patients in both treatment groups received a maximum of eight injections administered one by one once a week for eight times for treatment group A and once in a fortnight for eight times for treatment group B.
The treatment was completed within seven weeks for Arm A and within 14 weeks for Arm B. Independently of the treatment arm they had been assigned to, all the patients were followed for a period covering a total of 12 or 19 weeks or until disease progression. Safety parameters (primary objective) and efficacy parameters (secondary objective) were recorded. Upon completion of the treatment, one follow-up visit took place at week 12 (group A, only) or 19 (group B, only).
To protect the patients' safety, the first six patients were treated as described below:
- The first patient was hospitalized and kept under medical observation for 72h after administration of the first and second dose of the investigational product;
- After an observational period of 3 days following the second dose of the first patient, the second and the third patient were administered the first dose of the investigational product, hospitalized and kept under medical observation for 72h. The two patients were treated simultaneously or consecutively;
- After an observational period of 3 days after the second dose to the first three patients, an interim safety report was sent to the Ethics Committee;
- Additionally the next three patients were hospitalized, administered their first dose of the vaccine and kept under medical observation for 72h. The three patients were treated simultaneously or consecutively. 15 evaluable patients (which were randomized to one of the two treatment groups in equal numbers) 5 study sites in Austria and Hungary
- Conditions
- Ovarian Epithelial Cancer
- Being tested
- Procure
- 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.
ProcureBiological
The IMP (Investigational Medical Product) consists of 1.3*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO (Dimethyl sulfoxide), solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial. 8 vial will be injected on weekly administration basis to the patient.
ProcureBiological
The IMP consists of 1.3*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO, solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial, 8 vials will be injected into the patient on biweekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine weekly administration | Other | Not described Receives: Biological: Procure |
| Vaccine biweekly administration | Other | Not described Receives: Biological: Procure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters
Measured: from first treatment until up to 12 to 19 weeks
Secondary outcomes (4)
Number of circulating tumor cells in peripheral blood
Circulating tumor cells (CTCs) will be quantified prior vaccination and follow up. CTCs will be enriched from peripheral blood and characterized by specific biomarkers. Quantitation of CTCs will provide information about the stage of a malignancy, onset of disease progression and response of therapy.
Measured: from first treatment till up to 12 to 19 weeks
Immune monitoring - Number of autologous dendritic cells loaded with tumor specific antigens
Immune monitoring will be done prior vaccination and during treatment. The immune reaction of the patients will be surveyed by determination of the frequency of specific markers for T-Cells, activated T-cells,B-cells,NK (Natural Killer)-cells, NKT (Natural Killer T)-cells.Quantification of these cells will be done by multicolour FACS (Florescence activated cell sorting). This method will be applied to determine the effects of dendritic cell treatment on the patients immune system.
Measured: from first treatment until treatment visit 7 up to 12 weeks
time to progression (CA (Cancer Antigen)-125 and CT (Computer tomography)
Measured: from first treatment until up to 12 to 19 weeks
Overall survival
Measured: from first treatment until up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Research Technologies GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Imhof, Dr., Principal investigator, Hospital Korneuburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456065
- Sponsor's protocol ID
- LRT-I-L01 Ovar
- Status last verified
- Feb 2013
- First submitted
- 14 Sep 2011
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open, Randomized, Study to Investigate the Safety of Active Immunotherapy With Fully Mature, TERT-mRNA and Survivin - Peptide Double Loaded Dendritic Cells (DCs) in Subjects With Advanced Epithelial Ovarian Cancer, Enrolled in the Study Within Twelve Weeks After Completing Primary Therapy
- ClinicalTrials.gov ID
- NCT01456065
- Acronym / sponsor ID
- LRT-I-L01 Ovar
- Conditions
- Ovarian Epithelial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Life Research Technologies GmbHUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 20 Oct 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.
The purpose of this study is to investigate the safety of the active immune therapy based on the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and Survivin-peptide double loaded DCs (Dendritic Cells) [Procure®] in patients with advanced ovarian cancer, enrolled into the study within twelve weeks after completing primary therapy.
Detailed description
This is an uncontrolled, randomized, parallel-group, open-label phase I trial in patients with advanced epithelial ovarian cancer. Patients were randomized into treatment group A with weekly administration versus treatment group B with bi-weekly administration.
Patients in both treatment groups received a maximum of eight injections administered one by one once a week for eight times for treatment group A and once in a fortnight for eight times for treatment group B.
The treatment was completed within seven weeks for Arm A and within 14 weeks for Arm B. Independently of the treatment arm they had been assigned to, all the patients were followed for a period covering a total of 12 or 19 weeks or until disease progression. Safety parameters (primary objective) and efficacy parameters (secondary objective) were recorded. Upon completion of the treatment, one follow-up visit took place at week 12 (group A, only) or 19 (group B, only).
To protect the patients' safety, the first six patients were treated as described below:
- The first patient was hospitalized and kept under medical observation for 72h after administration of the first and second dose of the investigational product;
- After an observational period of 3 days following the second dose of the first patient, the second and the third patient were administered the first dose of the investigational product, hospitalized and kept under medical observation for 72h. The two patients were treated simultaneously or consecutively;
- After an observational period of 3 days after the second dose to the first three patients, an interim safety report was sent to the Ethics Committee;
- Additionally the next three patients were hospitalized, administered their first dose of the vaccine and kept under medical observation for 72h. The three patients were treated simultaneously or consecutively. 15 evaluable patients (which were randomized to one of the two treatment groups in equal numbers) 5 study sites in Austria and Hungary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine weekly administration | Other | Biological: Procure |
| Vaccine biweekly administration | Other | Biological: Procure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with epithelial ovarian cancer FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) stage III in remission after treatment with surgery (hysterectomy and ovariectomy) and after the first primary chemotherapy (standard treatment e.g. 6-9x Carboplatin/Taxane)
- Age > 18 ≤ 75 years
- Histological confirmed FIGO stage III ovarian epithelial cancer
- Stable disease at screening visit: negative CT and CA-125 within normal range
- Karnofsky status ≥ 70% and/or ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Key exclusion criteria (10 listed)
- Surgery, radiation therapy or chemotherapy within eight weeks prior to leukapheresis
- Other biological therapy (Interferons, TNF (Tumor necrosis factors), Interleukins, mABs (Monoclonal antibodies), biological response modifiers) within eight weeks prior to undergo the leukapheresis
- History or presence of systemic autoimmune disease (such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma or multiple sclerosis)
- Participation in other clinical trials or treatments with an investigational drug within four weeks prior to enrollment
- Serious intercurrent chronic or acute illness such as severe asthma or COPD (Chronic Obstructive Pulmonary Disease), cardiac (NYHA (New York Heart Association ) class III or IV) or hepatic disease, or other illness considered to constitute an unwarranted high risk for investigational drug treatment
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 |
|---|---|---|
| ProcureThe IMP (Investigational Medical Product) consists of 1.3*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO (Dimethyl sulfoxide), solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial. 8 vial will be injected on weekly administration basis to the patient. | Biological | Vaccine weekly administration |
| ProcureThe IMP consists of 1.3*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO, solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial, 8 vials will be injected into the patient on biweekly basis. | Biological | Vaccine biweekly administration |
Primary outcome
Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters
Time frame: from first treatment until up to 12 to 19 weeks
4 secondary outcomes
Number of circulating tumor cells in peripheral blood
Time frame: from first treatment till up to 12 to 19 weeks
Immune monitoring - Number of autologous dendritic cells loaded with tumor specific antigens
Time frame: from first treatment until treatment visit 7 up to 12 weeks
time to progression (CA (Cancer Antigen)-125 and CT (Computer tomography)
Time frame: from first treatment until up to 12 to 19 weeks
Overall survival
Time frame: from first treatment until up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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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.
Martin Imhof, Dr. principal investigator
Hospital Korneuburg
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Procure in people with Ovarian Epithelial Cancer, run by Life Research Technologies GmbH at 5 sites in 2 countries.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Hungary. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters (time frame: from first treatment until up to 12 to 19 weeks). 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 1 Mar 2013.