At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Cohort A: histologically proven early-stage or locally advanced colorectal, lung, or pancreatic cancer eligible for resection
- ✓Cohort B: metastatic RAS/BRAF-mutant colorectal, lung, or pancreatic cancer with ≥1 prior treatment line
- ✓Cohort C: metastatic cancer with RAS/BRAF mutation and liver metastases amenable to Y90 radioembolization
- ✕Uncontrolled cardiac disease including myocardial infarction within 3 months, symptomatic coronary artery disease, uncontrolled arrhythmias, unstable angina, or NYHA class III-IV heart failure
- ✕Uncontrolled intercurrent illness including uncontrolled infection, NYHA class III-IV symptomatic heart failure, uncontrolled arrhythmias, or psychiatric illness limiting compliance
- ✕HIV positive status
- ✕G6PD deficiency, hereditary spherocytosis, or conditions predisposing to hemolysis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies
In Brief
A Phase 2 clinical trial evaluating Vitamin C for Colorectal Cancer and 2 related conditions. Completed, enrolled 61 participants across 2 sites.
Detailed Summary
This is a multicenter, single arm, 3-cohort, open-label trial of high dose Vitamin C intravenous infusion in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with extended RAS (e.g.KRAS or NRAS) or BRAF mutation metastatic cancer who have received prior systemic treatment (cohort B). Cohort C will involve patients with colorectal cancer having an extended RAS or BRAF mutation who are amenable for localregional therapy of hepatic metastases with Yttrium-90 radioembolization.
Study Details
Timeline
Interventions
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.