Tecemotide (L-BLP25) in Prostate Cancer
This trial has been completed.
|Treatments||radiation therapy, goserelin, cyclophosphamide, tecemotide (l-blp25)|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2011|
|End date||October 2016|
|Trial size||28 participants|
|Trial identifier||NCT01496131, BB-IND 7787, EMR 63325-015|
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
|Intervention model||parallel assignment|
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) and Week 27 (approximately 2 months after radiation)
Change from Baseline in the ELISPOT Level of Mucin-1 specific T-cells at 6 Months After Radiation
time frame: Baseline (Day -16 to -1) and Week 40 (approximately 6 months after radiation)
Kaplan-Meier Estimates of Time to Disease Recurrence based on Prostate-specific antigen (PSA) Levels
time frame: Up to Month 24
Percentage of Subjects 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
Percentage of Subjects 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
Male participants at least 18 years old.
Inclusion Criteria: - 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 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 - 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
|Official title||A Randomized Phase II Study of Tecemotide in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Untreated, Intermediate and High Risk Prostate Cancer Patients|
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