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

Description

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.

Conditions

Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, NSCLC

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Study Overview

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Study Details

Study overview

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.

A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Iowa City

Holden Comprehensive Cancer Cener, Iowa City, Iowa, United States, 52242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Exudative pleural effusion
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Joseph J. Cullen, MD, FACS,

Joseph J Cullen, MD, FACS, STUDY_DIRECTOR, University of Iowa

Study Record Dates

2027-12-31