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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

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 SitesRockland, Massachusetts