Papaverine for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope, Duarte, CANon-Small Cell Lung Cancer+8 MorePapaverine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Stage II Lung Cancer
  • Stage III Lung Cancer
  • Stage IIIB Lung Cancer
  • Stage IIB Lung Cancer
  • Stage IIA Lung Cancer
  • Stage IIIA Lung Cancer
  • Non-Small Cell Lung Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Carboplatin
1
Papaverine Hydrochloride
2
Proton Beam Radiation Therapy

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: At 12 and 24 months post-treatment

6 weeks
Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT)
Month 24
Distant-metastasis-free survival
Local control rate
Primary tumor control rate
Month 24
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
Month 24
Disease-free survival
Month 24
Time to local-regional progression
Month 24
Overall survival

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Carboplatin
1
Papaverine Hydrochloride
3
Proton Beam Radiation Therapy

Trial Design

1 Treatment Group

Treatment (papaverine, RT, paclitaxel, carboplatin)
1 of 1

Experimental Treatment

28 Total Participants · 1 Treatment Group

Primary Treatment: Papaverine · No Placebo Group · Phase 1

Treatment (papaverine, RT, paclitaxel, carboplatin)Experimental Group · 5 Interventions: Paclitaxel, Carboplatin, Papaverine, Durvalumab, Radiation Therapy · Intervention Types: Drug, Drug, Drug, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Carboplatin
FDA approved
Papaverine
FDA approved
Durvalumab
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7130

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 and 24 months post-treatment

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
290 Previous Clinical Trials
286,111 Total Patients Enrolled
Jeremey Brownstein, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 24 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your condition cannot be treated through surgery.
You may have small amounts of fluid in your body that are too difficult to remove safely.
The doctor believes that you will live for at least 6 more months.
You are eligible to receive standard chemotherapy with radiation as part of the study treatment plan.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Ohio State University Comprehensive Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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