L-BLP25 (Stimuvax) in Prostate Cancer
This study is currently recruiting participants.
Verified January 2013 by EMD Serono
Sponsor:
EMD Serono
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
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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 June 18, 2013