Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Dendritic Cells (DC) prostate
Sponsored by
About this trial
This is an interventional trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Must be at least 45 years of age.
- Must have histologically confirmed adenocarcinoma of the prostate.
- Must have evidence of disease progression while on LHRH agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. All patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. Increasing PSA in three subsequent analysis.
- Must be ambulatory with a ECOG performance score of <2
- Lab.values as 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 < 20% above the upper limit of normal, ASAT and ALAT ( 2.5 the upper limit of normal. Albumin ( 2.5 g/L).
- Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
- Prior chemotherapy: a minimum of 4 weeks must have elapsed prior to entry in the study.
- If the patient has received strontium-89 and alpha-radin, at least three months must have elapsed prior to entry in the study.
- Informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the ICH-GCP Guidelines.
Exclusion Criteria:
- History of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin.
- Active infection requiring antibiotic therapy.
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- Autoimmune disease treated with steroid(s)
- History of asthma, anaphylaxis or other serious adverse reactions to vaccines.
- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis/dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
- Impending untreated spinal cord compression or urinary outlet obstruction.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Sites / Locations
- Oslo university Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01278914
Brief Title
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
Official Title
Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2002 (Actual)
Primary Completion Date
August 10, 2004 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PRIMARY OBJECTIVES:
Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood samples, and adverse events).
SECONDARY OBJECTIVES:
Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Study Phase
Phase 1, Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Dendritic Cells (DC) prostate
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 45 years of age.
Must have histologically confirmed adenocarcinoma of the prostate.
Must have evidence of disease progression while on LHRH agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. All patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. Increasing PSA in three subsequent analysis.
Must be ambulatory with a ECOG performance score of <2
Lab.values as 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 < 20% above the upper limit of normal, ASAT and ALAT ( 2.5 the upper limit of normal. Albumin ( 2.5 g/L).
Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
Prior chemotherapy: a minimum of 4 weeks must have elapsed prior to entry in the study.
If the patient has received strontium-89 and alpha-radin, at least three months must have elapsed prior to entry in the study.
Informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the ICH-GCP Guidelines.
Exclusion Criteria:
History of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin.
Active infection requiring antibiotic therapy.
Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
Autoimmune disease treated with steroid(s)
History of asthma, anaphylaxis or other serious adverse reactions to vaccines.
History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis/dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
Impending untreated spinal cord compression or urinary outlet obstruction.
Any reason why, in the opinion of the investigator, the patient should not participate.
Facility Information:
Facility Name
Oslo university Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
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