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Anti-tumor antibiotic

TACE for Lung Cancer

Phase 2
Recruiting
Led By Franz E Boas
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-small cell lung cancer (any stage), with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy
Lung-dominant disease (majority of active tumor volume is in the chest)
Timeline
Screening 1 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial tests a procedure (TACE) to control or stop the growth of lung tumors using chemotherapy and blocking off the tumor's blood supply.

Who is the study for?
Adults with non-small cell lung cancer that's gotten worse on standard treatments or who can't handle those treatments. They should have a majority of their tumor in the chest and not be candidates for surgery, thermal ablation, or ablative radiation. Excluded are pregnant individuals, those with certain heart and lung conditions, severe kidney failure, mental status changes affecting consent/follow-up, specific blood disorders, hyperthyroidism history including subclinical cases, allergies to trial drugs or iodinated contrast that can't be managed premedication.Check my eligibility
What is being tested?
The trial is testing transarterial chemoembolization (TACE) for treating non-small cell lung cancer. TACE involves injecting chemotherapy directly into the artery feeding the tumor along with substances to block this artery—trapping chemotherapy within the tumor and cutting off its nutrient supply.See study design
What are the potential side effects?
Possible side effects include pain at injection site; fever; abdominal pain; liver function abnormalities; nausea and vomiting due to chemotherapy; allergic reactions to mitomycin or lipiodol; complications from blocking blood vessels such as tissue damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is getting worse despite treatment, and surgery or targeted therapies are not options for me.
Select...
Most of my cancer is located in my chest.
Select...
I am 18 years old or older.

Timeline

Screening ~ 1 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 1 weeks for screening, Varies for treatment, and 6 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
Incidence of adverse events
Local progression free survival
Secondary outcome measures
Bronchial versus pulmonary artery blood supply
Growth of TACE targeted lesions versus non-TACE targeted lesions
Lipiodol retention in treated tumors
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lung chemoembolizationExperimental Treatment5 Interventions
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Mitomycin
2009
Completed Phase 3
~410
Transarterial Chemoembolization
2009
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,430 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
Franz E BoasPrincipal InvestigatorCity of Hope Medical Center

Media Library

Mitomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05672108 — Phase 2
Pleural Tumors Research Study Groups: Lung chemoembolization
Pleural Tumors Clinical Trial 2023: Mitomycin Highlights & Side Effects. Trial Name: NCT05672108 — Phase 2
Mitomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672108 — Phase 2

Frequently Asked Questions

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

Is the combination of TACE, mitomycin, ethiodized oil and embospheres certified by the FDA?

"Although there are some safety data for Treatment (TACE, mitomycin, ethiodized oil, embospheres), a Phase 2 trial implies that efficacy has yet to be established. We have assigned this treatment an interim rating of 2 on our scale from 1-3."

Answered by AI

Are there any volunteer opportunities available for this research study?

"As per the data hosted on clinicaltrials.gov, this trial is not seeking applicants at present. It was first posted on May 24th 2023 and updated lastly in January 3rd of that same year. Nevertheless, there are still 3689 other research studies actively recruiting patients right now."

Answered by AI

What outcome are researchers hoping for with this experiment?

"The primary outcome of this clinical trial, evaluated over a 6 month timeline starting from the initial TACE treatment to progression in a fully treated territory (or touching the border of such an area), or death from any cause is Adverse Event Incidence. Secondary objectives include Overall Survival estimated with Kaplan-Meier Methodology, Progression-Free Survival calculated via Kaplan Meier's approach and Bronchial versus Pulmonary Artery Blood Supply measured as proportions confidentially derived through Jeffreys Prior Interval."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Transarterial Chemoembolization for the Treatment of Lung Cancer
2023. "Transarterial Chemoembolization for the Treatment of Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05672108.
~11 spots leftby Oct 2024
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