Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients

NCT01334047 | Terminated Phase 1

• 1 other identifier: DC-006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Recurrent Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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.

  Every 4 weeks during vaccination and every 3-6 months during follow up

• Treatment free interval

  up to 5 years after vaccination

Study Arms (1)

DC vaccine

EXPERIMENTAL

Dendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT and Survivin.

Biological: DC-006 vaccine

Interventions

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.

Also known as: Dendritic cell vaccine

DC vaccine

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Steinar Aamdal: lead

Study Sites (1)

Oslo University Hospital- Norwegian Radium Hospital

Oslo, 0424, Norway

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

• Steinar Aamdal, M.D PhD Prof

  Oslo University Hospital - Norwegian Radium Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

NO (1)