RecruitingPhase 1NCT03467360

Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma


Sponsor

Centre Antoine Lacassagne

Enrollment

27 participants

Start Date

Aug 2, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy or radioimmunotherapy in small cell lung cancer due to: 1. The over-expression of carbonic anhydrases in this type of cancer, 2. The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines, 3. The observed synergy between irradiation and inhibition of carbonic anhydrases, 4. Potential anti-tumor immune effect caused by decreased extracellular acidity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial is testing whether adding acetazolamide (a drug that blocks an enzyme called carbonic anhydrase) to standard radiation and chemotherapy — or to immunotherapy — can make these treatments work better in patients with small cell lung cancer (a fast-growing type of lung cancer). **You may be eligible if...** - You are 18 or older - You have been diagnosed with small cell lung cancer that has not spread to distant organs (localized disease), OR extensive small cell lung cancer that has already received 4 cycles of chemotherapy plus immunotherapy - You are well enough to handle daily activities (performance status 0–2) - You are scheduled to begin radiation therapy combined with chemotherapy (for localized disease) - Women of childbearing age must have a negative pregnancy test and agree to use contraception **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have previously received radiation to the chest area - You have serious heart failure (ejection fraction below 30%) or severe lung disease (oxygen-dependent COPD, severely reduced lung function) - You have a contraindication to carbonic anhydrase inhibitors (such as sulfa drug allergy) - You are affiliated with a health insurance plan that does not cover the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGacetazolamide in combination with platinum and etoposide-based radiochemotherapy

Radiation therapy will be combined with platinum and etoposide-based chemotherapy combined with 3-6 tablets per day of acetazolamide during the entire course of therapy (dosage appropriate to the inclusion phase).

DRUGacetazolamide in combination with radioimmunotherapy in patients with extensive SCLC

acetazolamide in combination with radioimmunotherapy in patients with extensive SCLC


Locations(2)

Centre Antoine Lacassagne

Nice, France

Centre Hospitalier Princesse grace

Monte Carlo, Monaco

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NCT03467360


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