Pharmacological Ascorbate for Lung Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID: NCT02420314
Run by: Joseph J. Cullen, MD, FACS
People needed: 55
Starts: 2015-04-01
Expected to finish: 2022-08-27
Last updated by the study team: 2024-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Holden Comprehensive Cancer Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.