Actively Recruiting
Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2025-06-03
18
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level. vvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response. Participants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment. Active participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit. Effectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes. Previous human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.
CONDITIONS
Official Title
Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females age 18 to under 70 years at time of consent
- Histologically confirmed metastases from gastrointestinal tumors with molecular markers for MSI and KRAS
- For microsatellite stable tumors, failure or ineligibility for standard 1st and 2nd line chemotherapy
- For microsatellite instability-high tumors, failure or ineligibility for systemic immunotherapy
- Karnofsky Performance Status greater than 70
- Expected survival of at least 12 weeks
- Written informed consent obtained prior to study procedures
- Adequate bone marrow function: WBC between 2,000 and 50,000 cells/mm3, ANC over 1,000 cells/mm3, hemoglobin over 8 g/dL, platelet count over 100,000 cells/mm3
- Adequate renal function: serum creatinine less than or equal to twice the upper limit of normal
- Adequate liver function: serum bilirubin less than 1.5 times upper limit of normal
- Acceptable coagulation status: INR less than upper limit of normal plus 15%; ability to suspend anticoagulant therapy for biopsies and injection
- Women of childbearing potential must have negative pregnancy test
- Use of acceptable contraception methods plus barrier contraception from screening through 6 weeks after treatment
- Willingness to comply with all study procedures and follow-up
- Measurable disease based on RECIST 1.1 criteria
- At least one tumor at least 1 cm in diameter suitable for safe intra-tumoral injection
You will not qualify if you...
- Pregnant or nursing women
- Use of systemic corticosteroids or immunosuppressive medications within 2 weeks before treatment
- Significant immunodeficiency in participant or household contacts
- Clinically significant active infection or uncontrolled high-risk medical conditions
- Active eczema, psoriasis, or other inflammatory skin conditions
- Unstable cardiac disease including recent heart attack, unstable angina, heart failure, myocarditis, or ventricular arrhythmias within 6 months
- New York Heart Association class III-IV heart failure on active treatment
- Oxygen saturation below 90% at rest
- Radiation, chemotherapy, or immunosuppressive therapy within 2 weeks before screening and 4 weeks before treatment
- Severe systemic reaction to previous smallpox vaccination
- Medical conditions posing prohibitive risk or inability to safely complete tumor biopsies
- Household contacts who are children under 5 years old, or have active eczema, psoriasis, inflammatory skin conditions, or significant immunodeficiency unless alternate living arrangements are made
- Live virus vaccination within 60 days prior to treatment
- Inability or unwillingness to give informed consent or comply with protocol follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
P
Patrick Wagner, MD
CONTACT
A
AHN Clinical Trial Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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