Phase 2 Study of Adding Vitamin C to Chemotherapy and Radiation for Non-Small Cell Lung Cancer

Sponsor: Joseph J. Cullen, MD, FACS

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02905591

Provider View

This clinical trial is testing whether adding high doses of vitamin C to the usual treatment of chemotherapy and radiation can help treat non-small cell lung cancer (NSCLC). All participants will receive vitamin C along with their standard treatment.

Patient Parameters

Program Overview

This study is exploring if high-dose vitamin C, given alongside standard chemotherapy and radiation, can improve treatment for non-small cell lung cancer (NSCLC). The standard treatment involves chemotherapy drugs, carboplatin and paclitaxel, and radiation therapy. Participants will receive vitamin C through an IV in their arm during their radiation sessions. The active treatment phase lasts about 10 to 12 weeks, after which participants will continue with regular follow-up care for their cancer.

Description

In this study, patients with certain stages of non-small cell lung cancer (NSCLC) will receive standard treatment, which includes chemotherapy with paclitaxel and carboplatin, and radiation therapy. These chemotherapy drugs are given through a vein in the arm, and radiation is delivered using a machine outside the body. After this combined treatment, patients usually receive two more cycles of chemotherapy, known as consolidation chemotherapy.

This trial adds a high dose of vitamin C (75 grams) at specific times during the treatment. The vitamin C is given through an IV in the arm, three times a week while the patient is receiving radiation therapy. The IV will be running during the radiation sessions.

Participants will also have standard imaging tests for their cancer, such as CT scans, PET scans, and X-rays, and will provide blood samples to see how the vitamin C affects the body during treatment.

The active treatment phase lasts about 10 to 12 weeks. After this, participants will return to their regular cancer follow-up care and any additional treatments their doctors recommend. It is important for the study team to stay in contact with participants for long-term follow-up.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer through a biopsy or similar procedure.
  • Recommended to receive carboplatin and paclitaxel chemotherapy with radiation therapy.
  • Tumor or cancer spread must be at least 1 cm in size on a CT scan.
  • Doctor has determined the patient is healthy enough for chemotherapy and radiation.
  • Part of the lung cancer must be visible and measurable on a CT or MRI scan.
  • Platelet count of at least 100,000 cells per milliliter.
  • Creatinine level within normal limits or creatinine clearance of at least 60 mL/min.
  • Not pregnant and willing to use birth control during the study.

Exclusion Criteria

  • Fluid buildup in the chest that is not safe to drain.
  • Recurrence of non-small cell lung cancer.
  • Deficiency in the enzyme G6PD.
  • Currently using insulin or advised to use insulin.
  • Need for daily blood sugar checks.
  • Taking certain medications (warfarin, flecainide, methadone, amphetamines, quinidine, chlorpropamide) without possible substitution.
  • Previous radiation that would overlap with current treatment.
  • Participation in another clinical trial.
  • Uncontrolled illness.
  • Breastfeeding women.
  • HIV positive individuals on therapy due to interactions with high-dose vitamin C.

If all criteria are met, a 15-gram test dose of vitamin C will be given through an IV as the final screening step.

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