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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort b - up to 6 months cohort c - 16 weeks for reporting.

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.

Change in antitumor activity measured by pathologic response based on tumor regression grading in cohort A patients.

Maximal tolerated dose of high dose vitamin C in combination with Y90 radioembolization

Secondary outcome measures

Assessment of pharmacokinetics of high dose vitamin C plasma levels concentrations

Objective response rate (ORR)

Progression-free survival (PFS)

+1 more

Other 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 2018 Phase 2 trial • 20 Patients • NCT03148236

10%

Pericarditis

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin C

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: All SubjectsExperimental Treatment1 Intervention

Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ascorbic acid

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,467 Total Patients Enrolled

Stand Up To CancerOTHER

51 Previous Clinical Trials

40,233 Total Patients Enrolled

Manish Shah, MDPrincipal InvestigatorWeill Medical College of Cornell University

6 Previous Clinical Trials

346 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

Recent research and studies

clinicaltrials.govStudy

High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies

2017. "High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03146962.