Safety of Active Immunotherapy in Subjects With Ovarian Cancer

NCT01456065 | Unknown Phase 1 DMC

• 1 other identifier: LRT-I-L01 Ovar
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 5

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.

Conditions

Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters

  from first treatment until up to 12 to 19 weeks

Secondary Outcomes (4)

• Number of circulating tumor cells in peripheral blood

  from first treatment till up to 12 to 19 weeks

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

  from first treatment until treatment visit 7 up to 12 weeks

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

  from first treatment until up to 12 to 19 weeks

• Overall survival

  from first treatment until up to 96 weeks

Study Arms (2)

Vaccine weekly administration

OTHER

Biological: Procure

Vaccine biweekly administration

OTHER

Biological: Procure

Interventions

Procure BIOLOGICAL

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.

Vaccine weekly administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Life Research Technologies GmbH: lead

Study Sites (5)

Hospital Landeskrankenhaus Innsbruck

Innsbruck, 6020, Austria

Location

Hospital Korneuburg

Korneuburg, 2100, Austria

Location

Hospital Barmherzigen Schwestern

Linz, 4010, Austria

Location

Semelweis University

Budapest, 1083, Hungary

Location

National Oncology Institute

Budapest, 1122, Hungary

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Martin Imhof, Dr.

  Hospital Korneuburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: October 20, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

HU (2); AU (3)