Tecemotide (L-BLP25) in Prostate Cancer

• Status: Completed
• Trial end date: 2016-11-25
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Goserelin

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