Status:
COMPLETED
Tecemotide (L-BLP25) in Prostate Cancer
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
Eligibility Criteria
Inclusion
- Histopathologic documentation of prostate cancer confirmed at the institution of study enrollment prior to starting this study
- Newly diagnosed or previously untreated prostate cancer with intermediate or high risk features as defined in the protocol
- No evidence of metastatic disease on computed tomography (CT) / magnetic resonance imaging (MRI) or bone scans
- No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous contrast, allergic reaction or anaphylaxis (in subjects who have known contrast allergies) are allowed
- Eastern Co-operative Oncology Group (ECOG) performance status of 0-1
- Human leukocyte antigen (HLA)-A2 or A3 positive for immunologic monitoring
- Hematological and biochemical eligibility parameters as defined in the protocol
- No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder)
- Willing to travel to the study center(s) for follow-up visits
- Age greater than or equal to 18 years old
- Able to understand and sign informed consent
- Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last administration of immunotherapy
Exclusion
- 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
- Subjects should have no autoimmune diseases that have required treatment as specified in the protocol
- History of immunodeficiency diseases, hereditary or congenital immunodeficiencies
- Serious intercurrent medical illness
- A clinically significant cardiac disease
- Subjects who have received any prior therapy for prostate cancer
- Subjects who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis
- Subjects receiving any other investigational agents
- Contraindication to biopsy such as bleeding disorders, ratio of prothrombin time to partial thromboplastin time (PT/PTT) \>=1.5 times the upper limit of normal, artificial heart valve
- Contraindication to MRI such as subjects weighing \>136 kilograms, allergy to magnetic resonance (MR) contrast agent, subjects with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices
- Contraindication to radiation therapy such as pre-existing and active prostatitis or proctitis, inflammatory bowel disease or known genetic sensitivity to ionizing radiation, or history of prior radiation to the pelvis
Key Trial Info
Start Date :
October 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2016
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01496131
Start Date
October 24 2011
End Date
November 25 2016
Last Update
March 9 2018
Active Locations (1)
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1
Please Contact US Medical Information
Rockland, Massachusetts, United States