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Safety of Active Immunotherapy in Subjects With Ovarian Cancer

Primary Purpose

Ovarian Epithelial Cancer

Status

Unknown status

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Procure

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

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
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

Exclusion criteria:

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
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

Sites / Locations

Hospital Landeskrankenhaus Innsbruck
Hospital Korneuburg
Hospital Barmherzigen Schwestern
Semelweis University
National Oncology Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Vaccine weekly administration

Vaccine biweekly administration

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters

Secondary Outcome Measures

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.

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.

time to progression (CA (Cancer Antigen)-125 and CT (Computer tomography)

Overall survival

Full Information

NCT ID

NCT01456065

First Posted

September 14, 2011

Last Updated

February 28, 2013

Sponsor

Life Research Technologies GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01456065

Brief Title

Safety of Active Immunotherapy in Subjects With Ovarian Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Life Research Technologies GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Epithelial Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccine weekly administration

Arm Type

Other

Arm Title

Vaccine biweekly administration

Arm Type

Other

Intervention Type

Biological

Intervention Name(s)

Procure

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Procure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters

Time Frame

from first treatment until up to 12 to 19 weeks

Secondary Outcome Measure Information:

Title

Number of circulating tumor cells in peripheral blood

Description

Time Frame

from first treatment till up to 12 to 19 weeks

Title

Immune monitoring - Number of autologous dendritic cells loaded with tumor specific antigens

Description

Time Frame

from first treatment until treatment visit 7 up to 12 weeks

Title

time to progression (CA (Cancer Antigen)-125 and CT (Computer tomography)

Time Frame

from first treatment until up to 12 to 19 weeks

Title

Overall survival

Time Frame

from first treatment until up to 96 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 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 Exclusion criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Imhof, Dr.

Organizational Affiliation

Hospital Korneuburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Landeskrankenhaus Innsbruck

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Hospital Korneuburg

City

Korneuburg

ZIP/Postal Code

2100

Country

Austria

Facility Name

Hospital Barmherzigen Schwestern

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Semelweis University

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

National Oncology Institute

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

12. IPD Sharing Statement

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Safety of Active Immunotherapy in Subjects With Ovarian Cancer

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