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

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph J. Cullen, MD, FACS; University of Iowa
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Albumin-Bound Paclitaxel; Ascorbic Acid; Carboplatin; Paclitaxel

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.