rAd-IFN + Celecoxib + Gemcitabine for Mesothelioma
(INFINITE Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there are specific time requirements for stopping certain treatments before starting the trial, such as a 21-day gap for cytotoxic chemotherapy and a 30-day gap for monoclonal antibodies. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination rAd-IFN, Celecoxib, and Gemcitabine for treating mesothelioma?
Research shows that combining COX-2 inhibitors like Celecoxib with immunotherapy can enhance the immune response against tumors, potentially leading to tumor shrinkage in mesothelioma. Additionally, studies suggest that interferons, like rAd-IFN, can boost the effectiveness of chemotherapy drugs such as Gemcitabine, making this combination a promising approach for treating mesothelioma.12345
Is the combination of rAd-IFN, Celecoxib, and Gemcitabine safe for humans?
Celecoxib and Gemcitabine have been studied for safety in humans. Celecoxib, a nonsteroidal anti-inflammatory drug, has shown potential antitumor effects in mesothelioma models, while Gemcitabine has been evaluated in clinical trials for mesothelioma, indicating some level of safety data exists for these drugs in humans.45678
What makes the rAd-IFN + Celecoxib + Gemcitabine treatment unique for mesothelioma?
This treatment is unique because it combines rAd-IFN, which boosts the immune system to fight cancer, with Celecoxib, a drug that reduces inflammation and may enhance the immune response, and Gemcitabine, a chemotherapy drug. This combination aims to improve outcomes by targeting the cancer through multiple mechanisms, including reducing the tumor's ability to suppress the immune system and directly attacking cancer cells.245910
What is the purpose of this trial?
This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.Eligible patients will be randomized 1:1 to either:1. Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine2. Control group: Celecoxib followed by GemcitabinePatients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1.The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM
Research Team
Daniel Sterman, MD
Principal Investigator
NYU Langone Laura and Isaac Perlmutter Cancer Center
Eligibility Criteria
This trial is for adults with Malignant Pleural Mesothelioma who've had 1-2 prior treatments, including an anti-folate and platinum regimen. They must be able to undergo intrapleural therapy, have a life expectancy of at least 12 weeks, and be in good physical condition (ECOG status 0 or 1). Women must not be pregnant and agree to contraception; men also need to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rAd-IFN, celecoxib, and gemcitabine or celecoxib and gemcitabine alone
Follow-up
Participants are monitored for survival and safety every 6 months for up to 5 years
Treatment Details
Interventions
- Celecoxib Oral Product
- Gemcitabine
- rAd-IFN
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ferring Ventures Limited
Lead Sponsor
Trizell Ltd
Lead Sponsor
University of Pennsylvania
Collaborator