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CompletedPhase 2NCT02420314
Official study title

Pharmacological Ascorbate for Lung Cancer

Study summary

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care treatment of non-small cell lung cancer (NSCLC) in adults. All subjects will receive high-dose ascorbate in addition to the standard treatment.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPaclitaxel and Carboplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 20, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Joseph J. Cullen, MD, FACS

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Joseph J. Cullen, MD, FACS
Interventions being studied
Drug: Paclitaxel; Drug: Carboplatin; Drug: Ascorbic Acid
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • newly diagnosed stage IIIB or IV non -small cell lung cancer. The potential participant must not have received first-line cytotoxic therapy. Prior use of first-line EGFR inhibitors or ALK inhibitors is allowed if there was progression on therapy.
  • CNS metastasis is allowed if the metastasis is treated and there are no signs of progression following treatment. The potential participant must be off steroids for at least 3 days and be stable.
  • At least 18 years of age
  • ECOG performance status of 0, 1, or 2
  • absolute neutrophil count (ANC) of at least 1500 cells per mm³
  • platelet count of at least 100,000 cells per mm³
  • hemoglobin of at least 8 g/dL
  • creatinine within 1.5 times the upper limit of normal
  • total bilirubin within 1.5 times the upper limit of normal
  • ALT within 3 times the institutional upper limit of normal
  • AST within 3 times the institutional upper limit of normal
  • the participant must tolerate a 15g ascorbate test infusion (screening dose)
  • patients who received prior treatment with curative intent must have experienced a treatment-free interval of at least 6 months since the last treatment
  • the participant must not be pregnant, be willing to have a pregnancy test done if deemed necessary, and be willing to use adequate birth control during the study
  • not breastfeeding
  • independently able to provide consent (legally authorized representative and/or power of attorney is not allowed)
Reasons someone may not be able to joinExclusion criteria
  • known sensitizing EGFR mutations or ALK gene rearrangements if the participant has not yet tried EGFR or ALK inhibitor therapies. If the potential participant's biopsy did not allow for gene analysis (inconclusive, not enough tissue), the patient is considered eligible for the study. Enrollment on this clinical trial after progression on targeted therapy is allowed
  • 50% or greater PD-L1 expression (patients with unknown PD-L1 expression or when PD-L1 expression can't be determined due to insufficient tumor sample or other reasons remain eligible)
  • receiving warfarin therapy and cannot tolerate drug substitution
  • active hemoptysis within 1 week of screening (more than 1/2 teaspoon of blood per day)
  • actively receiving insulin at the time of ascorbate infusion
  • G6PD deficiency
  • leptomeningeal disease
  • potential participants cannot be on the following drugs: flecainide, methadone, amphetamines, quinidine, or chlorpropamide.
  • known active invasive malignancy other than the lung cancer under therapy (non-melanoma skin cancer or carcinoma in situ of the cervix or bladder are exempted)
  • potential participants may not enroll in, or be actively receiving treatment from, a therapeutic clinical trial for their cancer. Observational studies (including imaging studies) are acceptable.
  • uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
  • known HIV positive individuals cannot be enrolled in this trial because high-dose ascorbate is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral agents

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Holden Comprehensive Cancer CenterIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 20, 2024. Always confirm current availability with the study team.

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