Status:
RECRUITING
Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and how well papaverine hydrochloride and stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung cancer. Papaverine h...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of concurrent papaverine hydrochloride (PPV), and lung SBRT in patients with non-small cell lung cancer (NSCLC) or lung metastases. SECON...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven NSCLC for whom SBRT to a single lesion has been chosen as the primary treatment modality (planned dose 50 Gy in 4-5 daily fractions). Patients with lung metastases from solid tumors are eligible.
- Patients must have a tumor =\< 5 cm as defined by computed tomography (CT) largest axial dimension. Presence of adjacent nodules considered neoplastic in the same lobe or other ipsilateral lobe are allowed as long as the nodule(s) can be encompassed in an SBRT gross tumor volume (GTV) of =\< 5 cm, within 1 isocenter. Multiple isocenters are not allowed
- No prior radiation resulting in overlapping fields
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Must be able to undergo correlative research MRIs
- No active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis (IPF)
- No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism
- Within 30 days of registration: patients must have vital signs, history/physical examination, and laboratory studies (liver function tests, creatinine or creatinine clearance assessment)
- Life expectancy of at least 12 weeks in the opinion of investigator
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment. Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen
- Within 90 days of registration: pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV-1) and diffusion capacity of the lung for carbon monoxide (DLCO)
- Albumin \>= 2.5 g/dL (within 30 days of study registration)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (within 30 days of study registration)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (within 30 days of study registration)
- Creatinine =\< 1.5 x ULN or calculated creatinine \>= 50 mL/min, calculated by the Cockcroft-Gault formula or 24-hour urine creatinine clearance \>= 50 mL/min (within 30 days of study registration)
Exclusion
- History of another malignancy
- Exception: Subjects who have been disease-free for \>= 3 years, or subjects with a history of localized prostate cancer, in situ carcinoma (e.g. breast, cervix, oral cavity), differentiated thyroid neoplasm, completely resected non-melanoma skin cancer, are eligible
- Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
- Pregnancy or breastfeeding: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and for 4 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. No breastfeeding while patient is on study
- Patients with history of pneumonectomy
- Prior cytotoxic chemotherapy, molecularly-targeted agents (e.g. erlotinib, crizotinib), or immunotherapy unless \>= 2 weeks from last dose. Patients can start chemotherapy, immunotherapy, or other systemic therapy after completion of SBRT, but this should be planned for ≥ 2 weeks from last SBRT dose.
- History of active connective tissue disease (scleroderma), idiopathic pulmonary fibrosis, pneumonitis
- Hepatic insufficiency resulting in jaundice and/or coagulation defects, or not meeting laboratory values (albumin, total bilirubin, AST/ALT)
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03824327
Start Date
February 7 2019
End Date
December 31 2027
Last Update
January 8 2026
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210