Vector Delivery of the IL-12 Gene in Men With Prostate Cancer

NCT00406939 | Completed Phase 1

• 2 other identifiers: #H-6836P50CA058204
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the safety of IL-12 gene therapy for patients with recurrence of prostate cancer after radiation therapy and those with or without metastatic disease with a prostate gland intact. These, of course, would include recurrent prostate cancer after definitive radiation therapy. The prostate cancer will be treated with a prostatic injection of a replication-defective adenovirus vector delivering the IL-12 gene. Following virus injection, patients will be hospitalized for 23 hours for observation. Only one course of therapy will be administered. Each patient will be carefully monitored for toxic effects. Three to five patients will be tested with a low dose of virus and if there are no serious adverse side effects, the dose will be slowly escalated in subsequent groups of 3-5 patients or until unacceptable toxicity is reached. Effectiveness will be monitored by serum prostate-specific antigen (PSA), transrectal ultrasound of the prostate, prostate biopsy and comparison of survival times to historical survival times for patients with radiation recurrent prostate tumors. The primary objective of this initial study is to determine whether the treatment is associated with significant toxicity.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

Gene Therapy; Immunology; Phase I Clinical Trial

Outcome Measures

Primary Outcomes (1)

• To determine whether the treatment is associated with significant toxicity.

Secondary Outcomes (2)

• Collection of data on tumor responses produced by the study treatment.

• Collection data on immune responses induced by the study treatment.

Interventions

IL-12 gene GENETIC

Eligibility Criteria

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

You may qualify if:

• Men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after the hormone therapy, cryosurgery, and/or the completion of definitive radiation therapy for at least one year.
• Patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum PSA level on at least 3 separate occasions at least 2 weeks apart, and that the serum PSA be below 50 ng/ml.
• The patient will possess the ability to give informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study. (Informed Consent Document).
• Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol.
• Adequate renal function with serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 45 ml/min/m2.
• Platelet count greater than 100,000 platelets/mm3.
• Absolute neutrophil count greater than 1000/mm3.
• Hemoglobin greater than 8.5 mg/dl
• Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT).
• Bilirubin less than 2.5 mg/dl, SGOT and SGPT less than 2.0x normal.

You may not qualify if:

• Acute infection: Acute infection is defined as any viral, bacterial or fungal infection, which requires specific therapy.
• Symptomatic metastasis.
• Metastatic lesions in the CNS/spinal cord or organs that could become life or function threatening within 3 months.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine Scott Department of Urology

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Shalev M, Kadmon D, Teh BS, Butler EB, Aguilar-Cordova E, Thompson TC, Herman JR, Adler HL, Scardino PT, Miles BJ. Suicide gene therapy toxicity after multiple and repeat injections in patients with localized prostate cancer. J Urol. 2000 Jun;163(6):1747-50.

  PMID: 10799174 BACKGROUND

• Fujita T, Timme TL, Tabata K, Naruishi K, Kusaka N, Watanabe M, Abdelfattah E, Zhu JX, Ren C, Ren C, Yang G, Goltsov A, Wang H, Vlachaki MT, Teh BS, Butler EB, Thompson TC. Cooperative effects of adenoviral vector-mediated interleukin 12 gene therapy with radiotherapy in a preclinical model of metastatic prostate cancer. Gene Ther. 2007 Feb;14(3):227-36. doi: 10.1038/sj.gt.3302788. Epub 2006 Oct 5.

  PMID: 17024109 BACKGROUND

Related Links

• Scott Department Of Urology Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Brian J. Miles, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 4, 2006
• Study Start: June 1, 1998
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 10, 2008

Record last verified: 2008-07

Locations

US (1)