A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC
NCT ID: NCT02905591
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
43 participants
INTERVENTIONAL
2018-11-16
2027-12-31
Brief Summary
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Detailed Description
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This study adds 75 grams of ascorbate (vitamin C, sometimes called pharmacological ascorbate because the dose is so high) at specific timepoints in the therapy. The ascorbate is administered intravenously - through a vein in your arm.
Participants will:
* receive 75 grams of intravenous ascorbate 3 times per calendar week while they are receiving radiation therapy. The IV will be running while the radiation therapy is administered.
* undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays.
* provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy
This active therapy portion lasts for about 10 to 12 weeks. After that is done, participants go back to standard follow-up for their cancer and any additional therapy their doctors believe they need.
However, it is very important the investigators remain in contact with participants; they will have life-long follow-up for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Radiation Therapy
Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
Paclitaxel
Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
* the dose is 45 mg/m2 (standard dose)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standardized dose reductions are used
Carboplatin
Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
* Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standard dose reductions are used
Ascorbic Acid
Administered intravenously
* 75 grams per infusion; each infusion is about 2 hours
* 3 infusion per calendar week
* The infusion is actively running for at least 20 minutes when radiation begins
* May be given while chemotherapy is delayed due to low counts
* Dose reductions are not used
* Given for 6 to 7 weeks, depending on when radiation starts
Interventions
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Radiation Therapy
Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
Paclitaxel
Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
* the dose is 45 mg/m2 (standard dose)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standardized dose reductions are used
Carboplatin
Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
* Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standard dose reductions are used
Ascorbic Acid
Administered intravenously
* 75 grams per infusion; each infusion is about 2 hours
* 3 infusion per calendar week
* The infusion is actively running for at least 20 minutes when radiation begins
* May be given while chemotherapy is delayed due to low counts
* Dose reductions are not used
* Given for 6 to 7 weeks, depending on when radiation starts
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Holden Comprehensive Cancer Center
OTHER
Joseph J. Cullen, MD, FACS
OTHER
Responsible Party
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Bryan Allen
Assistant Professor, Department of Radiation Oncology
Principal Investigators
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Joseph J Cullen, MD, FACS
Role: STUDY_DIRECTOR
University of Iowa
Locations
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Holden Comprehensive Cancer Cener
Iowa City, Iowa, United States
Countries
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References
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Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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