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


Phase 1/Phase 2
45 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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 ┬Ámol/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.

Type of Study:

Interventional

Study Design:

N/A

Authority:

Norway: Norwegian Medicines Agency

Study ID:

DC Prostate

NCT ID:

NCT01278914

Start Date:

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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