L-BLP25 (Stimuvax) in Prostate Cancer

This study is currently recruiting participants.
Verified January 2013 by EMD Serono
Sponsor:
Collaborator:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01496131
First received: November 3, 2011
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

This study examines Stimuvax (L-BLP25) in combination with standard treatment for prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Radiation
Drug: Androgen Deprivation Therapy (ADT)
Other: Standard of care
Drug: L-BLP25
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T cells at 2 Months After Radiation. [ Time Frame: Baseline (Day -16 to -1) to Week 27 (approximately 2 months after radiation) ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T cells at 6 Months After Radiation. [ Time Frame: Baseline (Day -16 to -1) to Week 40 (approximately 6 months after radiation) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Kaplan-Meier Estimates of Time to Disease Recurrence based on Prostate-specific antigen (PSA) Levels [ Time Frame: up to month 24 ] [ Designated as safety issue: No ]
    To evaluate progression/recurrence status up to 24 months after randomization in patients receiving L-BLP25 vaccine in combination with the standard treatment versus patients receiving standard treatment alone.

  • Percentage of Participants with a Doubling in Number of T-cells in tumor biopsy from Baseline to Week 27 [ Time Frame: Baseline (Day -16 to -1) to Week 27 ] [ Designated as safety issue: No ]
    To analyze immunologic responses (in the tumor microenvironment) in patients consenting to undergo study biopsies.

  • Percentage of Participants with a Doubling of Number of T-cells in tumor biopsy from Baseline to Week 40 [ Time Frame: Baseline (Day -16 to -1) to Week 40 ] [ Designated as safety issue: No ]
    To analyze immunologic responses (in the tumor microenvironment) in patients consenting to undergo study biopsies.


Estimated Enrollment: 48
Study Start Date: November 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard therapy
Radiation therapy in combination with androgen deprivation therapy (ADT).
Drug: Radiation
Radiation therapy
Drug: Androgen Deprivation Therapy (ADT)
ADT
Experimental: Standard therapy plus L-BLP25
Radiation therapy in combination with androgen deprivation therapy plus L-BLP25 vaccine
Other: Standard of care
Standard of Care
Drug: L-BLP25
L-BLP25 with single dose of cyclophosphamide 3 days before the first vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496131

Locations
United States, Massachusetts
Contact US Medical Information in Rockland, MA for US Recruiting Sites Recruiting
Rockland, Massachusetts, United States
Contact: US Medical Information    888-275-7376      
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Martin Falk, MD Merck Serono S.A., Geneva
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01496131     History of Changes
Other Study ID Numbers: EMR 63325-015, BB-IND 7787
Study First Received: November 3, 2011
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Stimuvax
Prostate Cancer
Goserelin
Cyclophosphamide
Radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Cyclophosphamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 17, 2014