Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Androgens

Cyclophosphamide

Vaccines

Goserelin

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Hormonal

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

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

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

Radiation therapy

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.

Tecemotide (L-BLP25)

Medical Responsible

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

Tecemotide (L-BLP25) in Prostate Cancer

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

MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).

Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) "Phoenix criteria". These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter.

Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).

National Cancer Institute (NCI)

EMD Serono

Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.

Standard Therapy

Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.

Standard Therapy Plus Tecemotide (L-BLP25)

Total

Age, Continuous

Sex: Female, Male

Baseline population included all randomized subjects.

For primary outcome measure, antigen specific data was provided with updated technique. Enzyme-Linked ImmunoSpot technique was not done, but intracellular cytokine antigen specific responses was evaluated, which is now the lab technique used.

Merck KGaA Communication Center

Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, "Number of Participants Analyzed" signifies subjects evaluable for this outcome 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)

Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)

Analysis population included all subjects randomized in the study.

Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels

Pre-RT

Post-RT

Analysis population included only the subjects who were randomized and provided consent for biopsy and whose baseline measurement was considered as evaluable. Here, "number analyzed" signifies subjects evaluable at specified time point and "number analyzed"=0 signifies that no subjects were evaluable at the specified time point.

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)

Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after Androgen Deprivation Therapy (ADT).

Spots Global Cancer Trial Database for Tecemotide (L-BLP25) in Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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