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Virus Therapy

rAd-IFN + Celecoxib + Gemcitabine for Mesothelioma (INFINITE Trial)

Phase 3
Waitlist Available
Led By Daniel Sterman, MD
Research Sponsored by Trizell Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) status of 1 or 0
Female patients of non-childbearing potential must be either postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile upon entry into the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

INFINITE Trial Summary

This trial will compare the overall survival of patients with mesothelioma who receive a combination of adenovirus-delivered interferon alpha-2b, celecoxib, and gemcitabine versus celecoxib and gemcitabine alone.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests rAd-IFN given through the chest cavity along with Celecoxib and Gemcitabine versus just Celecoxib and Gemcitabine. The goal is to see if adding rAd-IFN improves survival. Patients are randomly assigned to either the treatment group receiving all three drugs or the control group receiving only two.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by IFN such as flu-like symptoms, fatigue, blood cell count changes, liver enzyme alterations, digestive issues like nausea or diarrhea from Gemcitabine/Celecoxib, and potential allergic responses.

INFINITE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a woman who cannot have children because I am postmenopausal or have been surgically sterilized.
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I am a male and will use double contraception from screening until 6 months after the last gemcitabine dose.
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My previous cancer treatments count as one line of therapy each.
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I am not pregnant and agree to use effective birth control during and for 1 month after the study.
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I am 18 years old or older.
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My cancer is confirmed as MPM and is mostly epithelioid.
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I've had 1 or 2 treatments for MPM, including chemo with anti-folate and platinum.

INFINITE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Best response
Progression Free Survival
Survival rate
Other outcome measures
Adenovirus type 5 neutralizing antibodies
Adverse Events Grade 3 or 4
Quality of Life; EQ-5D-5L Health Questionnaire
+3 more

INFINITE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control3 Interventions
rAd-IFN (Study Day 1) + celecoxib oral product (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 [i.e., Days 1 and 8 of the first gemcitabine treatment cycle], gemcitabine will be repeated every 3 weeks until disease progression/early termination [ET]
Group II: Control GroupPlacebo Group2 Interventions
Celecoxib oral product (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 [i.e., Days 1 and 8 of the first gemcitabine treatment cycle], gemcitabine will be repeated every 3 weeks until disease progression/ET.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,992 Previous Clinical Trials
42,875,307 Total Patients Enrolled
8 Trials studying Mesothelioma
224 Patients Enrolled for Mesothelioma
Trizell LtdLead Sponsor
Daniel Sterman, MDPrincipal InvestigatorNYU Langone Laura and Isaac Perlmutter Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

rAd-IFN (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03710876 — Phase 3
Mesothelioma Research Study Groups: Control Group, Treatment Group
Mesothelioma Clinical Trial 2023: rAd-IFN Highlights & Side Effects. Trial Name: NCT03710876 — Phase 3
rAd-IFN (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03710876 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the methods and procedures of Treatment Group approved by the Federal Drug Administration?

"There is some evidence that the treatment is effective, and it has been through multiple rounds of testing, so the safety of the treatment is estimated to be a 3."

Answered by AI

Have other groups of patients been treated with this method before?

"There are currently 505 ongoing clinical trials researching Treatment Group. Out of those, 141 have progressed to Phase 3. Although the majority of these studies originate from Woolloongabba, Queensland, there are 25431 total locations running these trials."

Answered by AI

What are the benefits of participating in Treatment Group?

"The urinary bladder is often treated with drugs from the Treatment Group. Drugs in the Treatment Group are also used to manage small cell lung cancer (sclc), pain, and head and neck carcinoma."

Answered by AI

Are there any opportunities for subjects to join this research?

"As of now, this study is not looking for more patients. The listing for this trial was first posted on January 21st, 2019 and was edited most recently on October 25th, 2021. If you are interested in other studies, there are 158 trials for patients with mesothelioma and 505 for patients in a Treatment Group."

Answered by AI

Are there other hospitals testing this out in our state?

"In addition to University of Maryland Medical Center in Baltimore, Maryland and NYU Clinical Cancer Center in New york, New York, this clinical trial is also enrolling patients from University of Pennsylvania Abramson Cancer Center in Philadelphia, Pennsylvania and 12 other locations."

Answered by AI
~9 spots leftby Mar 2025