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Platinum-based Chemotherapy

Papaverine + Chemoradiation for Lung Cancer

Phase 1
Recruiting
Led By Jeremey Brownstein, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 18 years old
Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 24 months post-treatment
Awards & highlights

Study Summary

This trial is testing whether papaverine, which targets mitochondrial metabolism, can decrease cancer growth when given with chemoradiation to patients with stage II-III non-small cell lung cancer.

Who is the study for?
Adults with stage II-III non-small cell lung cancer that hasn't spread beyond the original site and is considered inoperable. Participants must have a life expectancy over 6 months, be well enough for chemotherapy with radiation, and not have had certain other cancers or treatments within specific time frames. They should also not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of papaverine combined with chemoradiation therapy (using carboplatin and paclitaxel) on patients with non-small cell lung cancer. Papaverine aims to slow down cancer growth by targeting mitochondrial metabolism.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, blood count changes, potential organ inflammation due to papaverine, as well as skin reactions from radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My lung cancer is confirmed to be non-small cell type.
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My lung cancer is at stage II-III, according to the AJCC.
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My tests show no cancer cells in the fluid from my chest.
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I understand the need for birth control or abstinence during the study.
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My kidney function tests are within the required range.
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All my previous treatment side effects are mild, except for hair loss.
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I've had specific scans within the last 2 months due to my condition.
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I've had a recent check-up, blood tests, liver and kidney function tests, and if applicable, a pregnancy test.
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I have small fluid build-ups not visible on an X-ray and too minor to drain.
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I can take care of myself and am up and about more than half of my waking hours.
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I had a chest surgery over 3 weeks ago and have healed well.
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I can undergo standard chemotherapy with radiation (carboplatin + paclitaxel).
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My condition cannot be treated with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry until the time of death from any cause, assessed at 12 and 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry until the time of death from any cause, assessed at 12 and 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT)
Secondary outcome measures
Changes in blood-based biomarkers related to predict patients response to PPV + CRT
Changes in magnetic resonance imaging (MRI) blood oxygen level dependent (BOLD) response on MRI
Changes in tissue-based biomarkers related to predict patients response to PPV + CRT
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (papaverine, RT, paclitaxel, carboplatin)Experimental Treatment6 Interventions
Patients receive PPV IV or SC and undergo 5 fractions of RT per week. Patients also receive paclitaxel IV over 1 hour and carboplatin IV QW over 1-6 weeks or pemetrexed IV over 10 minutes followed by carboplatin IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 month of completing CRT, patients with PD-L1 positive disease receive durvalumab IV Q2W for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Papaverine
2019
Completed Phase 4
~310
Radiation Therapy
2017
Completed Phase 3
~7250
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3870
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,179 Total Patients Enrolled
Jeremey Brownstein, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05136846 — Phase 1

Frequently Asked Questions

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

What kind of health risks might patients take when they use Papaverine?

"Papaverine's safety was evaluated to be a score of 1, since this is an inaugural trial and there is minimal evidence confirming its efficacy or security."

Answered by AI

What is the highest amount of participants enrolled in this clinical experiment?

"Correct. Clinicaltrials.gov verifies that this medical research project, which was initially made public on December 6th 2021, is searching for suitable participants at present. The trial seeks 28 volunteers from a single site."

Answered by AI

Is enrollment for this clinical research still open to participants?

"According to the clinicaltrials.gov listing, this medical trial is still recruiting participants - with an initial post date of December 6th 2021 and a most recent update on April 18th 2022."

Answered by AI

Has Papaverine previously been studied in a medical setting?

"Currently, 1433 medical trials are being conducted on Papaverine. 365 of these research projects have reached the advanced phase 3 stage. Most of these studies occur in Shanghai; however, 74682 different sites worldwide are hosting clinical trials related to this drug."

Answered by AI

In what medical cases has Papaverine been prescribed?

"Papaverine is commonly used to combat advanced soft tissue sarcoma, yet its effects can also be useful in addressing recurrent and advanced cervical cancer."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Ohio State University Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Dec 2024