Is NCT07192900 recruiting in Pittsburgh, PA?

Yes, NCT07192900 is currently recruiting participants at its Pittsburgh, PA location. This malignant pleural effusion clinical trial is actively enrolling qualified participants.

How do I join the malignant pleural effusion 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.

Malignant Pleural Effusion Clinical Trial in Pittsburgh, PA

About This Malignant Pleural Effusion Study in Pittsburgh

This research study aims to evaluate the safety and effectiveness of a novel immunotherapy, Fast TIL, an Adoptive Cellular Therapeutic (ACT), to fight cancer that has spread to the pleura or pleural mesothelioma. The ACT product is created at AHN West Penn using the participant's pleural infiltrating T-cells (PIT). It is administered through a pleural catheter along with the drug Interleukin-2 (IL-2). Based on previous research it is believed that it may help fight the tumor and relieve symptoms. As a participant, their pleural fluid will be collected and the PIT cells will be isolated and expanded in the lab to create the ACT product. Before receiving the ACT product through their pleural catheter, they will undergo outpatient lymphodepleting chemotherapy. LDC is a standard procedure for many approved immunotherapy treatments Following the infusion, they'll receive IL-2 through the catheter for two days to stimulate the expanded PIT cells. The active treatment phase lasts about three weeks, with follow-up visits over five years at AHN West Penn Hospital, potentially requiring a hospital stay of up to six days. Blood samples will be taken to monitor their response. As this is a first-in-human study, treatment carries an unknown risk up to and including death from toxicity. However, the risks of similar immunotherapy treatments are well documented.

Sponsor: David Bartlett, MD

Who Can Participate

Inclusion Criteria

Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.

Patients will be ≥ 18 and \< 80 years of age.

Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 6 months after ACT administration. Male participants must be willing to practice birth control from the time of enrollment on this study and for 6 months after receiving the preparative regimen.

Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography.

No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.

Karnofsky performance score ≥ 70.

Patients must have an expected survival \> 12 weeks.

Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.

Patients must consent to collection of demographic and clinical data.

Exclusion Criteria

Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, and melanoma.

Infection with Human Immunodeficiency Virus (HIV) and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.

Infection with hepatitis B and active viral replication.

Infection with hepatitis C and active viral replication.

Patients currently being treated for bacterial, fungal or viral infection.

Documented myocardial infarction within 6 months of study participation and/or symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.

Investigational drug use within 30 days before effusion collection.

Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules.

Corticosteroid therapy \> 10 milligrams (mg) of prednisone (biological equivalent) daily within 2 weeks before effusion collection.

Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician.

Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease: AST/SGOT \> 2.0 times the upper limit of normal ALT/SGPT \> 2.0 times the upper limit of normal Total bilirubin \> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\>3.0 times the upper limit of normal) Hemoglobin \< 8 gm/dL or dependent upon transfusion to maintain ≥ 8 gm/dL White blood cell count \< 2,000/mm3 Platelet count \< 100,000/mm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL/min.

Pregnant or lactating females.

Prior solid organ transplantation

Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.

Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.

Patients with documented anaphylaxis as a result of penicillin allergy.

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 (NCT07192900) 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.

Malignant Pleural Effusion Treatment Options in Pittsburgh, PA

If you're searching for malignant pleural effusion treatment options in Pittsburgh, PA, this clinical trial (NCT07192900) 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 phase 1 clinical trial. You'll receive care from experienced malignant pleural effusion 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 malignant pleural effusion clinical trials near you to find additional studies recruiting in your area.

Malignant Pleural Effusion Clinical Trial in Pittsburgh, PA

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