A Randomized Phase II Study of L-BLP25 in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Newly Diagnosed, High Risk Prostate Cancer Patients
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Randomized Phase II Study of L-BLP25 in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Newly Diagnosed, High Risk Prostate Cancer Patients
Inclusion Criteria:
- Must have newly diagnosed prostate cancer with high risk features
- No evidence of metastatic disease on CT or bone scans
- No systemic steroid use within 2 weeks prior to initiation of experimental therapy
- ECOG performance status of 0-1, HLA-A2 or A3 positive for immunologic monitoring,
baseline renal function, hepatic function
Exclusion Criteria:
- No evidence of being immunocompromised by human immunodeficiency virus
- A medical condition requiring systemic steroids
- A medical condition requiring immunosuppressive therapy
- Splenectomy
- Active Hepatitis B or Hepatitis C
- A clinically significant cardiac disease
- Patients who have received any prior therapy for prostate cancer
- Patients who have known brain metastasis
- Patients receiving any other investigational agents
- Contraindication to biopsy
- Bleeding disorders
- Artificial heart valve
- Patients weighing >136 kilograms
- Allergy to MR contrast agent
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable
electronic devices
- Pre-existing and active prostatitis or proctitis
- Inflammatory bowel disease or known genetic sensitivity to ionizing radiation
- History of prior radiation to the pelvis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T cells at 2 Months After Radiation.
Outcome Description:
To determine impact of L-BLP25 vaccine in addition to standard treatment on the MUC1 specific systemic immune response in patients with newly diagnosed high risk prostate cancer L-BLP25 vaccine in combination with Androgen Deprivation Therapy (ADT) and radiation therapy.
Outcome Time Frame:
Baseline (Day -16 to -1) to Week 27 (approximately 2 months after radiation)
Safety Issue:
No
Principal Investigator
Martin Falk, MD
Investigator Role:
Study Director
Investigator Affiliation:
Merck Serono S.A., Geneva
Authority:
United States: Food and Drug Administration
Study ID:
EMR 63325-015
NCT ID:
NCT01496131
Start Date:
November 2011
Completion Date:
January 2016
Related Keywords:
- Prostate Cancer
- Stimuvax
- Prostate Cancer
- Goserelin
- Cyclophosphamide
- Radiotherapy
- Prostatic Neoplasms
Name | Location |
|---|---|
| Contact US Medical Information in Rockland, MA for US Recruiting Sites | Rockland, Massachusetts |
