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

Who is this study for? Patients with localized small cell lung cancer
What treatments are being studied? Acetazolamide+Combination with platinum and etoposide-based radiochemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> or = 18 years,

• Performance Status 0 to 2,

• Patient with an histologically non-metastatic localized (or extensive SCLC sub-group) Small cell lung cancer,

• Patient who must start radiotherapy treatment combined with chemotherapy with platinum and etoposide (localized SCLC sub-group) or Patient who received 4 cycles of chemoimmunotherapy with platinum salts, etoposide and immunotherapy (atezolizumab or durvalumab) as the first treatment (extensive SCLC sub-group) Note: The decision of the Multidisciplinary Consultation Team must be notified in the patient's medical file,

• Evaluation lesion according to the criteria RECIST 1.1 and / or according to the criteria PERCIST 1.0,

• Women of childbearing potential must have a negative serum pregnancy test within 72 hours of the first administration of the study treatment,

• If the patient is a woman of childbearing potential, she must be surgically sterile or agree to use two adequate methods of contraception throughout the duration of the study until 1 month after the last administration of the study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,

• If the male patient has one or more female partners of childbearing age, he / she must agree to use an adequate method of contraception, starting at the first administration of the study treatment up to 1 month after the last administration of the treatment. of the study, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,

• Patient willing and able to provide written informed consent/assent for the trial,

• Patient affiliated with a health insurance system.

Locations
Other Locations
France
Centre Antoine Lacassagne
RECRUITING
Nice
Contact Information
Primary
Jérôme DOYEN, PH
jerome.doyen@nice.unicancer.fr
+33492031270
Time Frame
Start Date: 2019-08-02
Estimated Completion Date: 2027-04-27
Participants
Target number of participants: 30
Treatments
Experimental: Localized SCLC
non randomized, open-label extension cohort, evaluating the safety of acetazolamide in combination with platinum and etoposide-based radiochemotherapy in patients with Localized small lung cancer
Other: Extensive SCLC
non randomized, open-label extension cohort, evaluating the safety of acetazolamide in combination with radioimmunotherapy in patients with extensive small cell lung cancer
Sponsors
Leads: Centre Antoine Lacassagne

This content was sourced from clinicaltrials.gov