Tecemotide (L-BLP25) in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Radiation therapy; Goserelin; Cyclophosphamide; Tecemotide (L-BLP25)
Intervention description: Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.; ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy.; Cyclophosphamide will be administered at a single dose of 300 milligrams per square meter (mg/m^2) to a maximum of 600 mg, as an intravenous injection 3 days prior to the first administration of tecemotide (L-BLP25).; Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.
Intervention MeSH terms: Cyclophosphamide; Goserelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tecemotide; Prostate Cancer; Goserelin; Cyclophosphamide; Radiotherapy

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