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Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278914
First Posted: January 19, 2011
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Biological: Dendritic Cells (DC) prostate Phase 1 Phase 2

Study Type: Interventional
Official Title: Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278914


Locations
Norway
Oslo university Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01278914     History of Changes
Other Study ID Numbers: DC Prostate
First Submitted: January 17, 2011
First Posted: January 19, 2011
Last Update Posted: July 22, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs