Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases

NCT03824327 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-18215NCI-2019-00105
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 hydrochloride may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with non-small cell lung cancer.

Conditions

Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Maximum-tolerated dose (MTD)

  Will employ the Bayesian optimal interval (BOIN) design to find the MTD.

  Up to 2 weeks

Secondary Outcomes (8)

• Primary tumor control

  At 12 and 24 months after stereotactic body radiation therapy (SBRT) completion

• Local control rate (primary tumor control + involved lobar control)

  Up to 12 months after SBRT completion

• Local-regional recurrence free-survival

  From time of entry onto study until the time of documented local-regional recurrence or death, assessed up to 12 months after SBRT completion

• Distant metastasis-free survival

  Time from entry onto study until the time of documented metastatic recurrence or death, assessed up to 12 months after SBRT treatment

• Disease-free survival

  Time from entry onto study until the time of any documented disease recurrence or death, assessed up to 12 months after SBRT completion

Study Arms (1)

Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)

EXPERIMENTAL

Patients undergo BOLD fMRI and receive papaverine hydrochloride IV on days -7 to day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks. Patients undergo CT scan throughout the study and blood sample collection on study.

Procedure: Blood Oxygen Level Dependent Imaging; Drug: Papaverine Hydrochloride; Radiation: Stereotactic Body Radiation Therapy

Interventions

Blood Oxygen Level Dependent Imaging PROCEDURE

Undergo BOLD fMRI

Also known as: Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging, BOLD, BOLD fMRI

Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)

Papaverine Hydrochloride DRUG

Given IV

Also known as: Cerebid, Cerespan, Pap H, Pavabid, Pavacap, Therapav, Vasal, Vaso-Pav, Vasospan

Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Papaverine; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeremy Brownstein, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 31, 2019
• Study Start: February 7, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)