Actively Recruiting
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-06-04
28
Participants Needed
2
Research Sites
264 weeks
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All previous treatment side effects must be mild or none (grade 1 or less) except hair loss at enrollment
- Absolute neutrophil count of at least 1.5 x 10^9/L
- Hemoglobin level of at least 9 g/dL
- Platelet count of at least 100 x 10^9/L
- Total bilirubin less than or equal to 1.5 times the upper normal limit
- AST and ALT liver enzymes less than or equal to 2.5 times the upper normal limit
- Creatinine less than 1.5 mg/dL or creatinine clearance of 50 mL/min or higher
- Age 18 years or older
- Confirmed diagnosis of non-small cell lung cancer by tissue or cell analysis
- Clinical stage II-III non-small cell lung cancer or select patients with limited metastatic disease
- Patients must be considered unresectable or not suitable for surgery if stage II-III
- Patients with local or regional recurrence after surgery who are recommended for chemoradiation
- Required PET/CT or CT scans and brain MRI or CT scans with contrast
- Vital signs, physical exam, and lab tests including blood counts, liver and kidney function within 14 days before enrollment
- ECOG performance status 0 to 2
- No history of complete heart block, liver dysfunction, glaucoma, or priapism
- At least 3 weeks since thoracotomy surgery and well healed
- Able to provide written informed consent
- Women of child-bearing potential must have a negative pregnancy test within 14 days
- Nursing women must have stopped nursing
- Men and women of reproductive potential must agree to use contraception or abstain during and after the study
- Suitable for standard chemotherapy and radiation during study treatment
- For MRI sub-study, consent to participate and enroll in expansion cohort or optional MRI study
You will not qualify if you...
- History of pneumonectomy surgery
- Active connective tissue disease like scleroderma or idiopathic pulmonary fibrosis
- Prior radiation therapy causing overlapping radiation fields
- Breastfeeding or positive pregnancy test
- Liver failure causing jaundice or abnormal liver labs
- Unable to complete or attempt first MRI scan in the sub-study
- Serious or unstable medical or psychiatric conditions interfering with safety or consent
- Unstable heart conditions or heart attacks within last 6 months
- AIDS diagnosis
- Recent severe lung disease requiring hospitalization within 30 days
- Current use of nitrates or nitroglycerin within 30 days before treatment
- Current use of sildenafil without planned discontinuation before and during study
- Contraindications to MRI such as pacemakers, metal implants, or severe claustrophobia
- Use of supplemental oxygen that cannot be stopped temporarily or breathing problems when lying down
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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