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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02905591
Other study ID # 201712770
Secondary ID 3P30CA0868625U01
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 16, 2018
Est. completion date December 31, 2027

Study information

Verified date August 2023
Source University of Iowa
Contact Bryan G Allen, MD, PhD
Phone 319-353-8836
Email bryan-allen@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.


Description:

For selected stages of non-small cell lung cancer (NSCLC), standard treatment involves radiation therapy and chemotherapy. The chemotherapy regimen typically used is paclitaxel and carboplatin. Both of these chemotherapeutic drugs are administered intravenously, using a vein in the arm. Radiation is administered using a machine external to the body (usually a linear accelerator). After combined therapy, NSCLC patients receive 2 extra cycles of chemotherapy, called "consolidation chemotherapy." 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.


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Study Design


Intervention

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Locations

Country Name City State
United States Holden Comprehensive Cancer Cener Iowa City Iowa

Sponsors (4)

Lead Sponsor Collaborator
Joseph J. Cullen, MD, FACS Holden Comprehensive Cancer Center, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum In: Cancer Cell. 2017 Aug 14;32(2):268. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression rate at completion of radiation and chemotherapy Tumor measurement from CT scan, using the RECIST criteria to define progression 3 to 4 weeks after last radiation treatment
Secondary Tumor response From radiation day 1 to documented disease progression as described by RECIST criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST. Every six months for up to 20 years post-treatment
Secondary Progression free survival (PFS) Time, measured in days, it takes for disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression Every six months for up to 20 years post-treatment
Secondary Overall survival (OS) Time, measured in months, from start of radiation to death from any cause. Every three months for up to 20 years post-treatment
Secondary Adverse event frequency and categorization Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows:
Through radiation, weekly assessment of adverse events
Consolidation chemotherapy, assessment day 1 of each cycle
Post-treatment, every 6 months through 2 years post-therapy
Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
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