A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

Last updated: January 14, 2025
Sponsor: Joseph J. Cullen, MD, FACS
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Carcinoma

Treatment

Ascorbic Acid

Paclitaxel

Radiation Therapy

Clinical Study ID

NCT02905591
201712770
1P01CA217797-01A1
3P30CA086862
5U01CA140206
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible

  • Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) ofnon-small cell lung cancer.

  • Recommended to receive carboplatin & paclitaxel with radiation therapy as atreatment

  • 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 radiationtherapy

  • 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 locallab 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

Exclusion Criteria:

  • Exudative pleural effusion

  • Recurrent non-small cell lung cancer

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

  • Patients actively receiving insulin or patients whose doctors have recommendedcurrent insulin use

  • Patients requiring daily finger-stick blood glucose measurements

  • Patients who are on the following drugs and cannot have a substitution or whodecline 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 interactionbetween 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.

Study Design

Total Participants: 46
Treatment Group(s): 4
Primary Treatment: Ascorbic Acid
Phase: 2
Study Start date:
November 16, 2018
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Holden Comprehensive Cancer Cener

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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