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

Part of paid clinical trials in Duarte, California.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT05136846
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Stage II Lung Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Unresectable Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Paclitaxel — DRUG
    Given IV
  • Papaverine — DRUG
    Given IV or SC
  • Radiation Therapy — RADIATION
    Undergo RT
  • Pemetrexed — DRUG
    Given IV
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated RT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Computed Tomography — PROCEDURE
    Undergo PET/CT or CT
  • Magnetic Resonance Imaging of the Brain with and without Contrast — PROCEDURE
    Undergo brain MRI
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Dec 6, 2021
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (papaverine, RT, paclitaxel, carboplatin)
    Patients receive PPV IV or SC over 30 minutes and patients receiving chemoradiation undergo 5 fractions of RT per week for 6 weeks or 5 fractions of hypofractionated RT per week for 3 weeks without chemotherapy. Patients undergoing chemoradiation receive paclitaxel IV and carboplatin IV QW over 1-6 weeks or pemetrexed IV followed by carboplatin IV every 3 weeks during radiation in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 positive disease may also receive durvalumab after completing CRT as considered clinically appropriate by the treating medical oncologist. Patients also undergo PET/CT or CT and brain MRI during screening, and blood sample collection, MRI and CT scans throughout the trial.

Primary Outcome Measure

Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT) or definitive hypofractionated radiation therapy [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Terrence Williams, MD
[email protected]
626-218-5677
Terrence Williams, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Jeremy M. Brownstein, MD
[email protected]
Jeremy Brownstein, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAOhio State University Comprehensive Cancer Center· Columbus, OH

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