What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), such as cisplatin and paclitaxel, which induce oxidative stress, are associated with side effects including nephrotoxicity, neurotoxicity, nausea, vomiting, and myelosuppression. High-dose ascorbate, which generates hydrogen peroxide to kill cancer cells, can cause gastrointestinal disturbances and, rarely, kidney stones due to increased oxalate levels.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include several drugs that induce cytotoxicity in cancer cells. Cemiplimab, a PD-1 inhibitor, has shown improved overall survival (OS) and progression-free survival (PFS) in patients with advanced NSCLC with high PD-L1 expression. Atezolizumab, another immunotherapy, has been approved for NSCLC and has demonstrated significant efficacy, although it comes with notable adverse reactions. These treatments, while not identical to high-dose ascorbate, share the common goal of inducing cytotoxic effects in cancer cells to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to high-dose ascorbate for NSCLC patients include: 1) Targeted therapies such as osimertinib for EGFR-mutant NSCLC and crizotinib for ALK-positive NSCLC. 2) Immunotherapies like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways. 3) Combination therapies that integrate immunotherapy with chemotherapy or other targeted agents. These alternatives have shown significant efficacy in clinical trials and are considered promising for NSCLC treatment in 2024.

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Platinum-based Chemotherapy

High-Dose Vitamin C + Chemotherapy for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Joseph J. Cullen, MD, FACS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed stage IIIB or IV non-small cell lung cancer with no prior first-line cytotoxic therapy

At least 18 years of age

Must not have

Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Active hemoptysis within 1 week of screening (more than 1/2 teaspoon of blood per day)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 months for up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding high doses of vitamin C to standard lung cancer treatment helps adults with non-small cell lung cancer. The idea is that vitamin C might make chemotherapy more effective.

Who is the study for?

Adults with newly diagnosed stage IIIB or IV non-small cell lung cancer who haven't had first-line cytotoxic therapy. They must have certain blood counts within normal ranges, be able to tolerate a vitamin C test dose, and not be pregnant or breastfeeding. Those with treated and stable brain metastasis can join; however, individuals with specific health conditions or on certain medications are excluded.

What is being tested?

The trial is testing the addition of high-dose ascorbate (vitamin C) to standard chemotherapy treatments Paclitaxel and Carboplatin for non-small cell lung cancer. All participants will receive this combination to see if it improves treatment outcomes.

What are the potential side effects?

High-dose vitamin C may cause side effects such as digestive discomfort, headache, fatigue, or skin reactions. Chemotherapy drugs like Paclitaxel and Carboplatin can lead to hair loss, nerve damage, nausea, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with advanced lung cancer and haven't received any initial strong chemotherapy.

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I am 18 years old or older.

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I can tolerate a vitamin C test dose.

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I can care for myself and am up and about more than 50% of my waking hours.

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I haven't had any cancer treatment for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have not coughed up more than half a teaspoon of blood daily in the past week.

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I have G6PD deficiency.

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I have no active cancer other than my lung cancer.

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My cancer has EGFR mutations or ALK rearrangements, and I haven't tried specific inhibitors.

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I am currently taking insulin during my ascorbate treatments.

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My cancer has spread to the lining of my brain and spinal cord.

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I am not taking flecainide, methadone, amphetamines, quinidine, or chlorpropamide.

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I am on warfarin and cannot switch to another medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 months for up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 months for up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor Response

Secondary study objectives

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ascorbate, paclitaxel, carboplatinExperimental Treatment3 Interventions

Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Ascorbic Acid

2017

Completed Phase 4

~2280

Paclitaxel

2011

Completed Phase 4

~5810

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, immunotherapy, and high-dose ascorbate. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as EGFR inhibitors, specifically target molecular abnormalities in cancer cells, minimizing damage to normal cells. Immunotherapy, including PD-1/PD-L1 inhibitors, boosts the body's immune system to recognize and destroy cancer cells. High-dose ascorbate (vitamin C) acts as a pro-oxidant, generating hydrogen peroxide to induce cytotoxicity selectively in cancer cells. This is significant for NSCLC patients as it offers a potential treatment that can enhance the efficacy of conventional therapies while potentially reducing their side effects.

Why Vitamin C Could Be an Excellent Complementary Remedy to Conventional Therapies for Breast Cancer.Mechanisms of anti-cancer effects of ascorbate: Cytotoxic activity and epigenetic modulation.Inhibition of epigallocatechin gallate-induced apoptosis by CoCl2 in human oral tumor cell lines.