A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2030-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph J. Cullen
• Collaborator: Holden Comprehensive Cancer Center
• Treatments: Gemcitabine

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)