Tecemotide (L-BLP25) in Prostate Cancer

NCT ID: NCT01496131

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-24
• Study Completion Date: 2016-11-25

Brief Summary

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard therapy

Radiation therapy in combination with androgen deprivation therapy (ADT).

Group Type: ACTIVE_COMPARATOR

Radiation therapy

Intervention Type: RADIATION

Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.

Goserelin

Intervention Type: DRUG

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.

Standard therapy plus tecemotide (L-BLP25)

Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).

Group Type: EXPERIMENTAL

Radiation therapy

Intervention Type: RADIATION

Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.

Goserelin

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Interventions

Radiation therapy

Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.

Intervention Type: RADIATION

Goserelin

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.

Intervention Type: DRUG

Cyclophosphamide

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).

Intervention Type: DRUG

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 Type: DRUG

Other Intervention Names

L-BLP25; BLP25 liposome vaccine; Epipepimut-S

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

Locations

Please Contact US Medical Information

Rockland, Massachusetts, United States

Countries

United States

Other Identifiers

BB-IND 7787

Identifier Type: OTHER

Identifier Source: secondary_id

EMR 63325-015

Identifier Type: -

Identifier Source: org_study_id