Gene Therapy for Prostate Cancer That Returns After Radiation Therapy

NCT00110526 | Withdrawn Phase 1 DMC

• 2 other identifiers: GCO # 01-0595A-11425
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to test a new treatment for prostate cancer. We have been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to control tumor growth. We propose to explore the use of adenovirus-mediated human interleukin-12 (Ad.hIL-12) in patients with recurrent non-metastatic prostate cancer following radiation therapy in a Phase I trial. Participants will be placed in rising dose groups with the primary endpoint of learning the maximum dose that can safely be given by injection directly into the prostate gland. Toxicity will be determined through physical examination, laboratory values, and blood levels of cytokines. Evidence of an immune response against prostate proteins will also be monitored. If the treatment works, the cancer will shrink or not grow. This will be monitored by prostate specific antigen (PSA) levels in the blood. However, we do not know if this treatment will be effective. If the PSA continues to rise after treatment, participants will be taken off study and offered other treatment. There is no compensation for participation in this research study. There will be no charge for the treatment with gene therapy or the monitoring associated with this research study. Monitoring will occur in a specially designated clinical research center.

Conditions

Prostatic Neoplasms; Neoplasm Recurrence, Local

Keywords

Prostate Cancer; Radiation Therapy; Local recurrence; Gene Therapy

Outcome Measures

Primary Outcomes (1)

• maximum cytokine gene therapy level

  To study in a Phase I clinical trial the safety of intraprostatic injection of a replication incompetent adenovirus expressing hIL-12 in patients with radiorecurrent prostate cancer

  after 56 weeks, every 6 months up to 15 years

Secondary Outcomes (10)

• serum pro-inflammatory cytokines levels

  up to 15 years

• To assess T cell responses pre and post-IL-12 treatment against prostate antigens

  Day 7 post vector injection

• To assess T cell responses pre and post-IL-12 treatment against prostate antigens

  Day 14 post vector injection

• To assess T cell responses pre and post-IL-12 treatment against prostate antigens

  Day 21 post vector injection

• To assess T cell responses pre and post-IL-12 treatment against prostate antigens

  Day 28 post vector injection

Study Arms (1)

Ad.hIL-12

EXPERIMENTAL

Genetic: Ad.hIL-12

Interventions

Ad.hIL-12 GENETIC

Ad.hIL-12 intraprostatic injection IND

Ad.hIL-12

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A local recurrence of prostate cancer (in or next to gland) following treatment by radiation therapy (either external beam or seed implantation)
• Rising PSA (Prostate Specific Antigen) on at least three occasions separated by two weeks
• Ultrasound guided biopsy to diagnose recurrent disease within the prostate
• No evidence of prostate cancer that has spread on bone scan or Computed Tomography (CT) scan
• No hormone therapy at time of enrollment to the research study

You may not qualify if:

• Radical prostatectomy for treatment of prostate cancer
• Detectable spread of prostate cancer on bone or CT scan
• Immunosuppressive medication within two months of the study
• Acute infection (any bacterial, viral, fungal infection requiring specific therapy)
• HIV disease
• Other significant medical or psychiatric conditions which pose high risk for an investigational study

Sponsors & Collaborators

• Simon Hall: lead
• U.S. Army Medical Research and Development Command: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Hall, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 10, 2005
• First Posted: May 11, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 24, 2013

Record last verified: 2013-10