Is NCT07001592 recruiting in Pittsburgh, PA?

Yes, NCT07001592 is currently recruiting participants at its Pittsburgh, PA location. This gastric neoplasms clinical trial is actively enrolling qualified participants.

How do I join the gastric neoplasms clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Gastric Neoplasms Clinical Trial in Pittsburgh, PA

About This Gastric Neoplasms Study in Pittsburgh

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.

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Who Can Participate

Inclusion Criteria

Males or females age, 18 to \< 70 years at the time of consent

Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.

For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.

Karnofsky Performance Status (KPS) of \> 70

Anticipated survival of at least 12 weeks.

Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures (subject or subject's legally authorized representative (LAR) must have the ability to understand and willingness to sign a written informed consent).

Adequate bone marrow function: WBC \> 2,000 and \<50,000 cells/mm3, ANC \> 1,000 cells/mm3, hemoglobin \>8 g/dL, and platelet count \>100,000 cells/mm3.

Adequate renal function: serum creatinine level ≤ 2xULN

Adequate liver function: Serum bilirubin \< 1.5 x ULN

Acceptable coagulation status: INR \< ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.

Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.

If sexually active, to prevent pregnancy and to prevent the spread of virus, subject must use an acceptable method of contraception as well as barrier contraception from screening through 6 weeks following study treatment with vvDD-hIL-2-RG-1.

Subjects must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.

Have measurable disease based on RECIST 1.1 criteria.

Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.

Exclusion Criteria

Pregnant or nursing an infant.

Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.

Significant immunodeficiency (e.g. due to underlying illness and/or medication) in subject or household contacts (must be able to avoid household contact with immunodeficient person for 3 weeks).

Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per investigator discretion.

Active eczema or psoriasis or other inflammatory skin conditions

Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI), unstable angina, congestive heart failure, myocarditis, ventricular arrhythmias diagnosed and requiring medication.

New York Heart Association functional class III-IV heart failure on active treatment

Pulse oximetry of \< 90% in room air at rest

Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy within 2 weeks prior to study screening and within 4 weeks prior to anticipated vvDD-hIL-2-RG-1 treatment.

Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.

Subjects who, in the opinion of the Investigator, have a medical condition that would subject the subject to prohibitive risk by participation in this study, or who may be unable to safely complete the required tumor biopsies.

Subjects with household contacts who are children \< 5 years old, have active eczema, psoriasis or other inflammatory skin conditions or have a significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus) and/or medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the study medication.

Vaccination with a live virus in the previous 60 days prior to Day 0.

Inability or unwillingness to give informed consent.

Is unable or unwilling to comply with protocol follow-up requirements. -

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT07001592) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Gastric Neoplasms Treatment Options in Pittsburgh, PA

If you're searching for gastric neoplasms treatment options in Pittsburgh, PA, this clinical trial (NCT07001592) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gastric neoplasms specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all gastric neoplasms clinical trials near you to find additional studies recruiting in your area.

Gastric Neoplasms Clinical Trial in Pittsburgh, PA

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