ACTIVE_NOT_RECRUITING

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

Conditions

Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer Non-Small-Cell Lung Carcinoma NSCLC pharmacological ascorbate ascorbic acid radiation chemotherapy carboplatin paclitaxel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-11-16

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02905591

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Joseph J Cullen, MD, FACS

STUDY_DIRECTOR

University of Iowa

Study Locations (Sites)

Holden Comprehensive Cancer Cener

Iowa City, Iowa, 52242

United States

Collaborators and Investigators

Sponsor: Joseph J. Cullen, MD, FACS

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-16

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2018-11-16

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

pharmacological ascorbate
ascorbic acid
radiation
chemotherapy
carboplatin
paclitaxel

Additional Relevant MeSH Terms

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