Clinical trial NCT01496131: Tecemotide (L-BLP25) in Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Tecemotide
Prostate Cancer
Goserelin
Cyclophosphamide
Radiotherapy
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-21
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
timeFrame: Baseline and Day 60 (Pre-Radiation)
measure: Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)
timeFrame: Baseline and Day 190 (Post-radiation)
Secondary outcomes:
measure: Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
timeFrame: From randomization up to 24 months
measure: Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)
timeFrame: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)
Other outcomes:
Locations:
city: Rockland
country: United States
facility: Please Contact US Medical Information
state: Massachusetts
Study officials:
affiliation: EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: