Using papaverine and targeted radiation therapy for lung cancer treatment

A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases

This study is trying to see if combining a medication called papaverine with targeted radiation therapy can help people with non-small cell lung cancer or lung metastases by making the tumors more responsive to the treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: erlotinib, crizotinib, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT03824327 on ClinicalTrials.gov

What this trial studies

This phase I trial investigates the safety and effectiveness of combining papaverine hydrochloride with stereotactic body radiation therapy (SBRT) in patients diagnosed with non-small cell lung cancer (NSCLC) or lung metastases. The study aims to determine how well this combination works in making tumor cells more sensitive to radiation while minimizing damage to surrounding healthy tissue. Patients will undergo functional MRI scans to assess blood oxygen levels and receive papaverine intravenously before SBRT sessions. The trial will also evaluate various survival rates and the potential of biomarkers to predict treatment response.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed NSCLC or lung metastases who are eligible for SBRT and have tumors measuring 5 cm or less.

Not a fit: Patients with active connective tissue diseases, idiopathic pulmonary fibrosis, or those who have had prior radiation in overlapping fields may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of radiation therapy for lung cancer patients, potentially leading to better treatment outcomes.

How similar studies have performed: While the combination of papaverine and SBRT is a novel approach, similar studies exploring the enhancement of radiation therapy with adjunctive agents have shown promise.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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)

Where this trial is running

Columbus, Ohio

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jeremy Brownstein, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center

Conditions Lung Non-Small Cell Carcinoma