A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

Launched by JOSEPH J. CULLEN, MD, FACS · Sep 16, 2016

Keywords

ClinConnect Summary

This clinical trial is studying whether adding high doses of vitamin C (also known as ascorbate) to the standard treatment for non-small cell lung cancer (NSCLC) can improve outcomes. The standard treatment includes radiation therapy along with two chemotherapy drugs, carboplatin and paclitaxel. All participants in this study will receive both the usual treatment and high-dose vitamin C to see if it makes a difference in how well the cancer responds.

To join the trial, participants must have a confirmed diagnosis of non-small cell lung cancer and be recommended to receive the standard treatment. They should be healthy enough to undergo chemotherapy and radiation, and their tumors need to be measurable by imaging tests like a CT scan. Participants will receive a test dose of vitamin C through an IV to ensure they can safely take it. It’s important to note that certain health conditions and medications may exclude individuals from participating. Overall, this trial is an opportunity for eligible patients to potentially benefit from an innovative treatment approach while contributing to important cancer research.

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Eligibility criteria

• Inclusion Criteria:
• • Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible
• • Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer.
• • Recommended to receive carboplatin \& paclitaxel with radiation therapy as a treatment
• • Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan)
• • Physician determined the patient is healthy enough for chemotherapy and radiation therapy
• • At least part of the lung cancer must be viewable and measurable by CT or MRI
• • A platelet count of at least 100,000 cells per mililiter
• • A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min\*1.73m2)
• • Not pregnant, and commit to using birth control during the study
• Exclusion Criteria:
• • Exudative pleural effusion
• • Recurrent non-small cell lung cancer
• • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• • Patients actively receiving insulin or patients whose doctors have recommended current insulin use
• • Patients requiring daily finger-stick blood glucose measurements
• * Patients who are on the following drugs and cannot have a substitution or who decline the substitution:
• • warfarin
• • flecainide
• • methadone
• • amphetamines
• • quinidine
• • chlorpropamide
• • Prior radiation therapy that would result in a field overlap
• • Enrolled in another therapeutic clinical trial
• • Uncontrolled, intercurrent illness
• • Lactating women
• • HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy
• • If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.