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Vitamin
Vitamin C for Colorectal Cancer
Phase 2
Waitlist Available
Led By Manish Shah, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort c - 16 weeks
Awards & highlights
Study Summary
This trial is testing high doses of Vitamin C given intravenously to people with different types of solid tumor cancer to see if it helps treat the cancer.
Eligible Conditions
- Colorectal Cancer
- Pancreatic Cancer
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort b - up to 6 months cohort c - 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort b - up to 6 months cohort c - 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.
Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
Pathologic Response Based on Tumor Regression Grading in Cohort A Patients
Secondary outcome measures
Maximum Concentration of Vitamin C in Hours in Cohort B
Objective Response Rate (ORR)
Progression-free Survival (PFS)
+2 moreOther outcome measures
Exploratory Biomarker Samples From Tumor Tissue Will be Collected at the Time Points Specified in the Protocol
In Vitro Activity of Vitamin C in Tumor Organoids
Pharmacodynamic Samples From Tumor Tissue Will be Collected at the Time Points Specified in the Protocol.
Side effects data
From 2023 Phase 2 trial • 61 Patients • NCT0314696275%
Back Pain
50%
Hypokalemia
25%
Edema Limbs
25%
Alkaline phosphatase increased
25%
Blood bilirubin increased
25%
Nausea
25%
Anemia
25%
Hypoalbuminemia
25%
Fever
25%
Abdominal distension
25%
Bloating
25%
Diarrhea
25%
Dizziness
25%
Urinary Frequency
25%
Periorbital edema
25%
Fatigue
25%
Hypertension
25%
Abdominal pain
25%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort C: Vitamin C + Y-90 Dose Level 3
Cohort C: Vitamin C + Y-90 Dose Level 5
Cohort C: Vitamin C + Y-90 Dose Level 6
Cohort A: Vitamin C + Surgery
Cohort B Vitamin C Only
Cohort C: Vitamin C + Y-90 Dose Level 1
Cohort C: Vitamin C + Y-90 Dose Level 2
Cohort C: Vitamin C + Y-90 Dose Level 4
Cohort C: Vitamin C + Y-90 Dose Level 7
Cohort C: Vitamin C + Y-90 Dose Level 8
Trial Design
10Treatment groups
Experimental Treatment
Group I: Cohort C: Vitamin C + Y-90 Dose Level 8Experimental Treatment1 Intervention
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Group II: Cohort C: Vitamin C + Y-90 Dose Level 7Experimental Treatment1 Intervention
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Group III: Cohort C: Vitamin C + Y-90 Dose Level 6Experimental Treatment1 Intervention
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Group IV: Cohort C: Vitamin C + Y-90 Dose Level 5Experimental Treatment1 Intervention
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Group V: Cohort C: Vitamin C + Y-90 Dose Level 4Experimental Treatment1 Intervention
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Group VI: Cohort C: Vitamin C + Y-90 Dose Level 3Experimental Treatment1 Intervention
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Group VII: Cohort C: Vitamin C + Y-90 Dose Level 2Experimental Treatment1 Intervention
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Group VIII: Cohort C: Vitamin C + Y-90 Dose Level 1Experimental Treatment1 Intervention
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Group IX: Cohort B: Vitamin C OnlyExperimental Treatment1 Intervention
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months.
Group X: Cohort A: Vitamin C + SurgeryExperimental Treatment1 Intervention
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic acid
FDA approved
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,237 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,275 Total Patients Enrolled
Manish Shah, MDPrincipal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
349 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unoccupied slots in this clinical trial available to participants?
"Correct. Clinicaltrials.gov confirms this medical study is actively seeking participants, with the trial being posted on March 29th 2017 and revised most recently on October 3rd 2022."
Answered by AI
What ailments have been remedied by Vitamin C supplementation?
"Vitamin C is an effective remedy for Vitamin A deficiency and other ailments like catarrh, vitamin insufficiency, and vitamin supplementation."
Answered by AI
What potential dangers can arise from consuming excessive amounts of Vitamin C?
"Based on the Phase 2 clinical trial, Vitamin C's safety is estimated to be at a level of 2. While there is evidence indicating its security profile, no data currently exists that supports its efficacy."
Answered by AI
What is the enrollment capacity of this clinical trial?
"Affirmative. Clinicaltrials.gov provides evidence that this research endeavour is presently recruiting participants, having been first listed on March 29th 2017 and most recently updated October 3rd 2022. 78 individuals are sought to join the trial at two select sites."
Answered by AI
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