Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Hyperplasia

Hyperplasia

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Vasodilator Agents

Urological Agents

All Drugs and Chemicals

Papaverine

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Placebo

papaverine

Treatment of patients with prostatic hyperplasia with topical papaverine.

Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.

Prostatic Hyperplasia Treatment and Cancer Prevention

Treatment of Prostatic Hyperplasia With Topical Papaverine

Manchanda Medical Clinic

Principal Investigator

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Folic Acid Antagonists

Antibodies, Monoclonal

Tubulin Modulators

Antimitotic Agents

Folic Acid

Vitamin B Complex

Antineoplastic Agents, Immunological

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

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.

Radiation Therapy

The Ohio State University Comprehensive Cancer Center

Terrence Williams, MD

Jeremy M. Brownstein, MD

Jeremy Brownstein, MD

Jeremey Brownstein, MD

This phase I trial finds out the best dose, possible benefits and/or side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.

PRIMARY OBJECTIVE:

I. To determine the maximally tolerated dose of papaverine (PPV) in combination with chemoradiation (CRT) and immunotherapy in patients with unresectable locally advanced (LA) non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To estimate the rates of primary tumor control, local control, time to local-regional progression, disease-free survival (DFS), and overall survival (OS). II. To assess whether blood oxygen level determination (BOLD) functional magnetic resonance imaging (MRI) studies can predict which patients may respond best to PPV + CRT, and detect changes in oxygenation before and after PPV administration.

III. To assess whether blood-based and tissue-based biomarkers can predict which patients may respond best to PPV + CRT.

OUTLINE: This is a dose-escalation study of PPV.

Patients receive PPV intravenously (IV) or subcutaneously (SC) and undergo 5 fractions of radiation therapy (RT) per week for 6 weeks. Patients also receive paclitaxel IV over 1 hour and carboplatin IV once weekly (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 every 2 weeks (Q2W) for 12 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) or CT and brain magnetic resonance imaging (MRI) during screening, and blood sample collection and CT scans throughout the trial. Patients may also undergo two additional research MRI scans between day -7 and -1.

After completion of the study treatment, patients are followed for 2 years at 1, 3, 6, 9, 12, 16, 20, and 24 months, then periodically for up to 5 years.

Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer

A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer

Will employ the Bayesian optimal interval (BOIN) design to find the MTD. Treatment-related toxicity will be assessed based on Common Terminology Criteria for Adverse Events version 5.0 criteria.

Defined as the absence of primary tumor failure. Will be calculated and 95% exact binomial confidence interval will be provided.

Defined as the absence of local failure, which is a combination of primary tumor and involved lobe failure. Will be calculated and 95% exact binomial confidence interval will be provided.

Will be summarized using Kaplan-Meier method.

Images pre and post PPV will be analyzed for stability of baseline and treatment signals. Percent BOLD change will be determined for maximal and overall signal changes. Comparisons between the distributions of pre and post PPV will be valuated using Earth Mover's Distance.

Will acquire measurements of circulating serum microRNAs that can indicate tumor hypoxia or response to therapeutic intervention, and alterations in immune cell subsets that are suggestive of immune system activation or suppression with the experimental therapy

When biopsy tissue is available, will acquire gene expression profiles by Affymetrix gene chip for indications of tumor hypoxia or response to therapeutic intervention, and correlating tumor mutations in genes involved in the anti-oxidant response pathway with outcomes.

Ohio State University Comprehensive Cancer Center

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.

Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.

Normal saline

Young-Kug Kim, MD,PhD

The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery.

The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.

Effect of Papaverine on Renal Artery Blood Flow Volume

Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study

Renal artery blood flow 2 minutes after papaverine administration by doppler sonography

estimated glomerular filtration rate using KIDGO equation

glomerular filtration rate using renal scan

Asan Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostatic Hyperplasia Treatment and Cancer Prevention	NCT03064282	Prostatic Hyper...	Placebo papaverine	50 Years - 70 Years	Manchanda Medical Clinic
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer	NCT05136846	Locally Advance... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Unresectable Lu...	Carboplatin Durvalumab Paclitaxel Papaverine Radiation Thera... Pemetrexed	18 Years -	Ohio State University Comprehensive Cancer Center
Effect of Papaverine on Renal Artery Blood Flow Volume	NCT04162834	Kidney Cancer	Papaverine Normal saline	20 Years - 79 Years	Asan Medical Center
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer	NCT05136846	Locally Advance... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Unresectable Lu...	Carboplatin Durvalumab Paclitaxel Papaverine Radiation Thera... Pemetrexed	18 Years -	Ohio State University Comprehensive Cancer Center
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer	NCT05136846	Locally Advance... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Unresectable Lu...	Carboplatin Durvalumab Paclitaxel Papaverine Radiation Thera... Pemetrexed	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for papaverine

Every month we try and update this database with for papaverine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for papaverine

Every month we try and update this database with for papaverine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for papaverine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.