Phase 1 Trial of Interleukin 12 Gene Therapy for Metastatic Pancreatic Cancer

NCT03281382 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 11260
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 trial will investigate the toxicity of combining interleukin 12 gene therapy with standard chemotherapy in metastatic pancreatic cancer.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity of the gene therapy

  grade 1 - 5 CTCAE adverse events

  21 days

Secondary Outcomes (2)

• >= grade 3 adverse events

  21 days

• PET imaging

  14 days

Study Arms (1)

Investigational Arm

EXPERIMENTAL

Patients will receive a single intratumoral injection of the oncolytic Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at one of three dose levels. Two days later, subjects will be administered (orally) 7 days of 5-fluorocytosine (5-FC) prodrug therapy. Fourteen days after completion of the 5-FC prodrug therapy course, subjects will be administered chemotherapy at the discretion of the treating physician. On an optional basis, subjects will be administered \[18F\]-FHBG, a HSV-1 TK substrate, and will undergo PET imaging to quantify the intensity, persistence, and biodistribution of HSV-1 TK gene expression in the pancreas.

Biological: Ad5-yCD/mutTKSR39rep-hIL12

Interventions

Ad5-yCD/mutTKSR39rep-hIL12 BIOLOGICAL

Oncolytic adenovirus expressing two suicide genes and human IL-12

Investigational Arm

Eligibility Criteria

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

You may qualify if:

• Histologically proven (biopsy or cytology) metastatic pancreatic adenocarcinoma.
• Age ≥ 18 years.
• No prior treatment (surgery, chemotherapy, radiotherapy, or biological therapy) for the study cancer.
• Zubrod performance score of 0 - 2 within 30 days of registration.
• Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:
• Adequate renal function with serum creatinine ≤ 1.8 mg/dL or creatinine clearance ≥ 50 mL/min/m2.
• Absolute neutrophil count \> 1,000/μL.
• Hemoglobin \> 8.0 g/dL.
• Platelet count \> 100,000/μL.
• Bilirubin \< 2.0 mg/dL.
• SGOT and SGPT \< 3.0 times upper limit of normal (ULN). Subjects with liver metastases may have SGOT/SGPT \< 5.0 times ULN.
• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout and for 60 days beyond the treatment phase of the study.
• Subjects on oral warfarin anticoagulation therapy may be included in this study, but must have close monitoring of their coagulation parameters as altered parameters and/or bleeding have been reported in patients taking Xeloda® and such agents concomitantly. Subjects on other forms of anti-coagulation therapies may need close clinical monitoring for signs or symptoms of bleeding.
• The subject 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.

You may not qualify if:

• Pregnant and lactating women.
• Clinical or laboratory evidence of pancreatitis, based on discretion of treating physician.
• Serious non-malignant disease (e.g., congestive heart failure or uncontrolled infections), which, in the opinion of the investigator would compromise study objectives.
• Major surgery planned within 3 months of registration other than diagnostic procedures such as laparoscopy or endoscopic ultrasound and stenting or PEG/PEJ placement.
• Islet cell tumor, benign cyst, peri-ampullary carcinoma or any non-adenocarcinomas.
• Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required specific therapy within 72 hours of initiation of the study therapy (defined as day 1).
• Previous history of liver disease including hepatitis.
• Positive serologic test for Hepatitis B or C at baseline.
• 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 on the protocol.
• Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Center for Cancer Surgery

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: July 1, 2017
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)