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Iowa City, Iowa 52242

  • Pancreatic Neoplasm

Purpose:

This is a phase 2 study testing the initial efficacy of adding pharmacological ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.


Study summary:

This phase 2 study is designed to determine the efficacy of adding pharmacological ascorbate (vitamin C) to standard chemoradiation. The ascorbate is infused before, during, and after the external beam radiation therapy treatment. Each ascorbate infusion is 75 grams (roughly the same amount of vitamin C from 1,000 oranges). For patients eligible for this trial, standard treatment for their cancer includes radiation therapy combined with weekly gemcitabine (a chemotherapy). Participants will: - decide if they want to receive the investigational treatment (pharmacological ascorbate plus gemcitabine plus radiation) or standard treatment only (gemcitabine plus radiation) - receive pharmacological ascorbate intravenously ascorbate during their daily radiation therapy treatments, if they choose the investigational treatment. - receive gemcitabine (a chemotherapy) once a week for up to 6 weeks of therapy (all participants) - receive radiation treatments are given once a day, Monday through Friday (all participants). - have routine doctor's visits and be asked about any side effects they are experiencing (all participants). This is a phase 2 study to determine the effect, if any, adding pharmacological ascorbate will have on standard therapy for pancreatic cancer. The study will also record any side effects of adding ascorbate to standard therapy. Once the patient completes radiation, the ascorbate infusions are also completed. However, the patient will need to return for regular follow-up care at University of Iowa.


Criteria:

Inclusion Criteria: To be eligible to participate in this study, an individual must meet ALL of the following criteria: - Ability and willingness to provide informed consent (power of attorney and legally authorized representatives are not accepted for informed consent) - Stated willingness to comply with all study procedures and availability for duration of the study - At least 18 years of age - Histologic or cytologic diagnosis of pancreatic adenocarcinoma - Recommended to receive gemcitabine-based chemoradiation - Good performance status (ECOG of 0, 1, or 2; KPS of > 50) - No other active malignancy that requires immediate treatment. Low grown concurrent cancers are acceptable with the appropriate documentation from the treating oncologists for that additional primary disease. - Not experiencing an uncontrolled illness such as infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other condition that would limit compliance with the study requirements or unacceptably increase risk to the participant (as determined by study team members). - Agree to abstain from alcohol and specified over the counter supplements during study treatment Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participating in this study: - Glucose-6-phosphate dehydrogenase (G6PD) deficiency - HIV positive individuals requiring anti-retroviral drug therapy (high-dose ascorbate is known to interact with many of these drugs) - Platelet count of <100,000 k/mm3 - Prior radiation that would result in field overlap (this will be determined by the study's radiation oncologist) - Actively receiving insulin - Other therapy (including radiation therapy) within 2 calendar weeks of study therapy - On any of the following drugs and cannot or will not accept a drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide - Other investigational agents (PET or SPECT imaging agents are acceptable) - Other investigational therapy with the intention to treat the disease under study - Pregnancy - Individuals declining to use acceptable birth control during the duration of the study - Lactating women who decline to discontinue breastfeeding their child (women may withhold breast feeding and resume under the direction of their medical oncologist after completion of study)


NCT ID:

NCT03541486


Primary Contact:

Principal Investigator
Joseph J. Cullen, MD, FACS
University of Iowa

Joseph J. Cullen, MD, FACS
Phone: (319) 353-8297
Email: joseph-cullen@uiowa.edu


Backup Contact:

Email: bryan-allen@uiowa.edu
Bryan G. Allen, MD, PhD
Phone: (319) 356-3693


Location Contact:

Iowa City, Iowa 52242
United States

Sandy Vollstedt, RN, BSN, OCN
Phone: 319-353-7143
Email: sandy-vollstedt@uiowa.edu

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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