Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer

NCT ID: NCT02555397

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2024-01-22

Brief Summary

The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single

Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.

Group Type: EXPERIMENTAL

Ad5-yCD/mutTKSR39rep-hIL12

Intervention Type: BIOLOGICAL

Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1

Interventions

Ad5-yCD/mutTKSR39rep-hIL12

Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Biopsy-proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy
• Evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir
• PSA < 100 ng/mL
• Age ≥ 18 years
• Karnofsky performance status ≥ 70
• Negative lymph nodes as established by imaging (pelvic CT or pelvic MRI)
• No evidence of metastatic disease, as evaluated by bone scan and CT scan of the abdomen and pelvis.
• Subjects must have adequate baseline organ function as assessed by the the following laboratory values:
• Adequate renal function with serum creatinine ≤ 1.5 mg/dL
• Platelet count > 100,000/µL
• Absolute neutrophil count > 1,000/µL
• Hemoglobin > 10.0 g/dL
• Bilirubin > 1.5 mg/dL
• AST/SGOT and ALT/SGPT < 3.0 times upper limit of normal (ULN)
• Men of child-producing potential must be willing to consent to use effective contraception for at least 3 months after the gene therapy
• Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study

Exclusion Criteria

• PSA ≥ 100 ng/mL
• Prostate volume > 100 cc
• Pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but biopsy negative are allowed.
• Evidence of M1 metastatic disease
• Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects must be disease-free for > 5 years
• Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
• If the subject had prior androgen deprivation therapy (ADT), the subject exhibited biochemical failure while on ADT
• Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowed; however, subjects must be > 2 years post-completion of chemotherapy at the time of registration. Subjects on Proscar therapy must stop to be eligible)
• Major surgery planned within 3 months of registration
• Severe, active co-morbidity defined as:
• New York Health Association Class II or greater congestive heart failure or active ventricular arrhythmia requiring medication
• Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within last 3 months or precluding study therapy at the time of registration
• Acute infection
• Previous history of liver disease including hepatitis
• Immunosuppressive therapy including systemic corticosteroids (use of inhaled and topical corticosteroids is permitted)
• Impaired immunity or susceptibility to serious viral infections
• Allergy to any product used in the protocol. If the subject has an allergy to Ciproflaxin, another antibiotic can be substituted at the discretion of the treating physician
• Serious medical or psychiatric illness or concomitant medication, which, in the judgement of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial

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

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Farzan Siddiqui

Senior Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

References

Freytag SO, Barton KN, Zhang Y. Efficacy of oncolytic adenovirus expressing suicide genes and interleukin-12 in preclinical model of prostate cancer. Gene Ther. 2013 Dec;20(12):1131-9. doi: 10.1038/gt.2013.40. Epub 2013 Jul 11.

Reference Type: BACKGROUND

PMID: 23842593 (View on PubMed)

Nyati S, Stricker H, Barton KN, Li P, Elshaikh M, Ali H, Brown SL, Hwang C, Peabody J, Freytag SO, Movsas B, Siddiqui F. A phase I clinical trial of oncolytic adenovirus mediated suicide and interleukin-12 gene therapy in patients with recurrent localized prostate adenocarcinoma. PLoS One. 2023 Sep 15;18(9):e0291315. doi: 10.1371/journal.pone.0291315. eCollection 2023.

Reference Type: DERIVED

PMID: 37713401 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Prostate Cancer (9829)

Identifier Type: -

Identifier Source: org_study_id