CompletedNCT03146962Updated May 2, 2024Results posted

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

A Phase 2 interventional study of Vitamin C in Colorectal Cancer, Pancreatic Cancer and Lung Cancer, sponsored by Weill Medical College of Cornell University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Weill Medical College of Cornell University · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 61
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

This clinical trial is for men and women with resectable or metastatic solid tumor malignancies. The objective of the study is to investigate whether high dose vitamin C infusion leads to pathological tumor response in resectable colorectal, pancreatic, and lung cancer (cohort A) or objective tumor response in KRAS or BRAF mutant solid tumors (cohort B). For Cohort C, the primary objective is to determine that maximal tolerated dose of the combination of high dose vitamin C with Y90 radioembolization for patients solid tumor malignancies and liver metastases amenable to local-regional therapy

Patients in cohort A receive a high dose vitamin C infusion for 4 days per week for 2-4 consecutive weeks prior to surgery. Patients in cohort B receive high dose vitamin C infusion for 4 days per week for up to 6 months or disease progression. 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.

A tumor sample will be resected after completion of study drug (high dose vitamin C infusion) treatment to examine the effects of study drug (Cohort A only). In addition, organoids will be grown in vitro and continue to be treated with vitamin C added in culture medium to examine tumor response. The resected tumor in this study will

Key eligibility:

Men and women age 18 and older
Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection, and have not received chemotherapy or radiotherapy (cohort A) Patients with inoperable, metastatic, KRAS or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, who have received at least 1 line of treatment for metastatic disease (cohort B)
Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).

Conditions studied

Colorectal Cancer
Pancreatic Cancer
Lung Cancer

In context

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female ≥ 18 years of age.
Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection (cohort A).
Patients with inoperable, metastatic extended RAS (e.g. KRAS or NRAS) or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, or other solid tumor, who have received at least 1 line of treatment for metastatic disease (cohort B).
Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).
ECOG performance status 0-1.
Life expectancy of at least 6 months.
All women of child-bearing potential and all sexually active male patients must agree to use effective contraception.

Exclusion criteria

Exclusion Criteria:

Patients with uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (Appendix B: New York Heart Association (NYHA) Classifications).
Patients with active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV) (Appendix B: New York Heart Association (NYHA) Classifications).
Patients who have received an investigational drug within 21 days of the first dose of study drug.
Patients who are pregnant or lactating.
Patients who are known to be positive for the human immunodeficiency virus (HIV). The effect of Vitamin C on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.
Patient who are receiving drugs which are known to interact with Vitamin C, potential risk and eligibility will be evaluated individually by the investigator. a. Most of the known interactions with vitamin C are from oral use and acidification of the stomach lining. There are few known interactions with high dose intravenous vitamin C. We recommend not using deferoxamine as there may be an association with ventricular dysfunction (unknown mechanism).
Patients who have uncontrolled or severe hyponatremia, hypernatremia, SIADH, hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia
Patients who have uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding.
Patients who require therapeutic doses of warfarin
Patients who have uncontrolled seizure disorder, ascites, iron overload, edema, or dehydration.
Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis.
Patients who have a known history of recurrent oxalate renal calculi or multiple oxalate.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 61 participants (actual)

Study arms

Experimental
Cohort A: Vitamin C + Surgery
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks.
Drug: Vitamin C
Experimental
Cohort B: Vitamin C Only
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 1
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 2
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 3
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 4
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 5
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 6
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 7
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.
Drug: Vitamin C
Experimental
Cohort C: Vitamin C + Y-90 Dose Level 8
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.
Drug: Vitamin C

Interventions

DrugVitamin C
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.
Also known as: Ascorbic Acid

What researchers measure

Primary outcomes

Pathologic Response Based on Tumor Regression Grading in Cohort A Patients
Number of patients with partial or complete pathological response in surgically resected tumor tissue: Pathological response rate is the number of patients with partial or complete pathological response in surgically resected tumor tissue. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is \>50% residual cancer cells within the tumor specimen.
Time frame: cohort A - 8 weeks
3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.
Percentage of patients with complete response, partial response, or stable disease as a result of their therapy at 3 months
Time frame: Cohort B - 3 months
Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
Maximal tolerated dose will be evaluated by assessment of dose limiting toxicities for multiple dose levels. Dose limiting toxicity will be defined as any grade 3-4 adverse event possibly, probably, or definitely attributed to vitamin C therapy in the 21 days of protocol therapy. In any group of 3 patients, if one patient experiences dose limiting toxicity, the group will be expanded by 3 additional patients (eg. 6 for that group). If, at any dose level, 2 or more patients experience a dose limiting toxicity, the maximal tolerated dose will be reached, and further dose escalation will not be pursued. The dose level may then be expanded up to 10 additional patients to confirm the safety and toxicity at that dose level.
Time frame: Cohort C - 16 weeks

Secondary outcomes

Progression-free Survival (PFS)
PFS is defined as the time from registration to cancer progression or death due to any cause for up to 6 months. Cancer progression is defined using the Response Evaluation Criteria in Solid Tumors v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
Time frame: cohort B - up to 6 months
Objective Response Rate (ORR)
Number of patients with a partial response or complete response based on RECIST 1.1 Criteria.
Time frame: cohort B - up to 6 months cohort C - 16 weeks
Time to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B
The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the Tmax and t(1/2) in hours
Time frame: Up to 24 hours post-infusion
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
The number of participants per cohort who experienced a Grade 3 or 4 adverse event (as defined by CTCAE v4.03) that was deemed possibly, probably, or definitely related to Vitamin C.
Time frame: Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration.
Maximum Concentration of Vitamin C in Hours in Cohort B
The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the maximum concentration (Cmax) in mM.
Time frame: Up to 24 hours post-infusion

Other outcomes

In Vitro Activity of Vitamin C in Tumor Organoids
Molecular signature of vitamin C efficacy will be determined using RNA sequencing and compared between KRAS or BRAF mutant vs wild type tumors. Organoids will be prepared from resected tumor samples and treated with vitamin C.
Time frame: cohort A - 8 weeks, cohort B - up to 6 months
Exploratory Biomarker Samples From Tumor Tissue Will be Collected at the Time Points Specified in the Protocol
To explore potential correlation of gene expression pattern with anti-tumor activity of vitamin C, we plan to perform RNA sequencing using surgical sample in cohort A patients who will receive vitamin C infusion pre-operatively.
Time frame: cohort A - 8 weeks, cohort B - up to 6 months, Cohort C - 16 weeks
Pharmacodynamic Samples From Tumor Tissue Will be Collected at the Time Points Specified in the Protocol.
Immunohistochemical (IHC) staining for GLUT1 protein expression will be performed on Formalin Fixed Paraffin Embedded (FFPE) tumor tissues. Immunohistochemical (IHC) staining for phosphor-AMPK will be performed on Formalin Fixed Paraffin Embedded (FFPE) tumor tissues to assess AMPK activation.
Time frame: cohort A - 8 weeks, cohort B - up to 6 months, Cohort C - 16 weeks

Results

Posted May 2, 2024

Participant flow

Participant flow — Overall Study
Milestone	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8
Started	7	21	3	3	4	3	3	7	3	7
Completed	5	15	3	3	3	3	3	6	3	6
Not completed	2	6	0	0	1	0	0	1	0	1
Withdrew: Lost to follow-up	1	1	0	0	0	0	0	0	0	0
Withdrew: Adverse event	0	3	0	0	0	0	0	1	0	0
Withdrew: Withdrawal by subject	0	0	0	0	1	0	0	0	0	0
Withdrew: Death	0	1	0	0	0	0	0	0	0	0
Withdrew: Covid precautions	1	0	0	0	0	0	0	0	0	0
Withdrew: Physician decision	0	0	0	0	0	0	0	0	0	1
Withdrew: Started new treatment	0	1	0	0	0	0	0	0	0	0

Outcome measures

PrimaryPathologic Response Based on Tumor Regression Grading in Cohort A Patients

Number of patients with partial or complete pathological response in surgically resected tumor tissue: Pathological response rate is the number of patients with partial or complete pathological response in surgically resected tumor tissue. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is \>50% residual cancer cells within the tumor specimen.

Time frame:: cohort A - 8 weeks
Reported as:: Count of participants · Participants

Pathologic Response Based on Tumor Regression Grading in Cohort A Patients
Participants	Cohort A: Vitamin C + Surgery
Pathologic Response Based on Tumor Regression Grading in Cohort A Patients	1

Primary3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.

Percentage of patients with complete response, partial response, or stable disease as a result of their therapy at 3 months

Time frame:: Cohort B - 3 months
Reported as:: Count of participants · Participants

3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.
Participants	Cohort B: Vitamin C Only
3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.	1

PrimaryMaximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization

Maximal tolerated dose will be evaluated by assessment of dose limiting toxicities for multiple dose levels. Dose limiting toxicity will be defined as any grade 3-4 adverse event possibly, probably, or definitely attributed to vitamin C therapy in the 21 days of protocol therapy. In any group of 3 patients, if one patient experiences dose limiting toxicity, the group will be expanded by 3 additional patients (eg. 6 for that group). If, at any dose level, 2 or more patients experience a dose limiting toxicity, the maximal tolerated dose will be reached, and further dose escalation will not be pursued. The dose level may then be expanded up to 10 additional patients to confirm the safety and toxicity at that dose level.

Time frame:: Cohort C - 16 weeks
Reported as:: Number · g/kg

Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
g/kg	Cohort C: Vitamin C + Y-90 (All Dose Levels)
Vitamin C Weekly Infusion Dose	1.25
Vitamin C Infusion Dose the Day of Y-90 Radioembolization	1.25

SecondaryProgression-free Survival (PFS)

PFS is defined as the time from registration to cancer progression or death due to any cause for up to 6 months. Cancer progression is defined using the Response Evaluation Criteria in Solid Tumors v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.

Time frame:: cohort B - up to 6 months
Reported as:: Median · days

Progression-free Survival (PFS)
days	Cohort B: Vitamin C Only
Progression-free Survival (PFS)	36 (14 to 151)

SecondaryObjective Response Rate (ORR)

Number of patients with a partial response or complete response based on RECIST 1.1 Criteria.

Time frame:: cohort B - up to 6 months cohort C - 16 weeks
Reported as:: Count of participants · Participants

Objective Response Rate (ORR)
Participants	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8
Objective Response Rate (ORR)	0	0	0	0	0	0	1	1	0

SecondaryTime to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B

The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the Tmax and t(1/2) in hours

Time frame:: Up to 24 hours post-infusion
Reported as:: Mean · hours

Time to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B
hours	Cohort B: Vitamin C Only
T(max)	2.28 ± 0.38
t(1/2)	6.46 ± 1.44

SecondarySafety of High Dose Vitamin C Administration Using CTCAE 4.03.

The number of participants per cohort who experienced a Grade 3 or 4 adverse event (as defined by CTCAE v4.03) that was deemed possibly, probably, or definitely related to Vitamin C.

Time frame:: Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration.
Reported as:: Count of participants · Participants

Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Participants	Cohort B: Vitamin C Only	Cohort C: Vitamin C + Y-90 Dose Level 3	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 8
Alkaline Phosphatase Increase	2	0	1	0
Aspartate Aminotransferase Increase	2	0	3	0
Alanine Aminotransferase Increase	3	0	1	0
Anemia	1	0	1	1
Hypokalemia	0	0	0	1
Blood Bilirubin Increased	0	0	1	0
Hypertension	0	1	0	0
Fatigue	0	0	1	0
Generalized Muscle Weakness	1	0	1	0
Confusion	1	0	0	0
Scrotal Pain	0	0	0	1
Syncope	1	0	0	0
Hemolysis	1	0	0	0

SecondaryMaximum Concentration of Vitamin C in Hours in Cohort B

The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the maximum concentration (Cmax) in mM.

Time frame:: Up to 24 hours post-infusion
Reported as:: Mean · mM

Maximum Concentration of Vitamin C in Hours in Cohort B
mM	Cohort B: Vitamin C Only
Maximum Concentration of Vitamin C in Hours in Cohort B	41.19 ± 10.89

Other pre-specifiedIn Vitro Activity of Vitamin C in Tumor Organoids

Molecular signature of vitamin C efficacy will be determined using RNA sequencing and compared between KRAS or BRAF mutant vs wild type tumors. Organoids will be prepared from resected tumor samples and treated with vitamin C.

Time frame:: cohort A - 8 weeks, cohort B - up to 6 months

Results for this outcome have not been posted.

Other pre-specifiedExploratory Biomarker Samples From Tumor Tissue Will be Collected at the Time Points Specified in the Protocol

To explore potential correlation of gene expression pattern with anti-tumor activity of vitamin C, we plan to perform RNA sequencing using surgical sample in cohort A patients who will receive vitamin C infusion pre-operatively.

Time frame:: cohort A - 8 weeks, cohort B - up to 6 months, Cohort C - 16 weeks

Results for this outcome have not been posted.

Other pre-specifiedPharmacodynamic Samples From Tumor Tissue Will be Collected at the Time Points Specified in the Protocol.

Immunohistochemical (IHC) staining for GLUT1 protein expression will be performed on Formalin Fixed Paraffin Embedded (FFPE) tumor tissues. Immunohistochemical (IHC) staining for phosphor-AMPK will be performed on Formalin Fixed Paraffin Embedded (FFPE) tumor tissues to assess AMPK activation.

Time frame:: cohort A - 8 weeks, cohort B - up to 6 months, Cohort C - 16 weeks

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort A: Vitamin C + Surgery	0/7 (0%)	0/7 (0%)	6/7 (85.7%)
Cohort B Vitamin C Only	1/21 (4.8%)	4/19 (21.1%)	18/19 (94.7%)
Cohort C: Vitamin C + Y-90 Dose Level 1	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort C: Vitamin C + Y-90 Dose Level 2	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort C: Vitamin C + Y-90 Dose Level 3	0/4 (0%)	0/4 (0%)	3/4 (75%)
Cohort C: Vitamin C + Y-90 Dose Level 4	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort C: Vitamin C + Y-90 Dose Level 5	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort C: Vitamin C + Y-90 Dose Level 6	2/7 (28.6%)	4/7 (57.1%)	7/7 (100%)
Cohort C: Vitamin C + Y-90 Dose Level 7	0/3 (0%)	0/3 (0%)	2/3 (66.7%)
Cohort C: Vitamin C + Y-90 Dose Level 8	1/7 (14.3%)	2/6 (33.3%)	5/6 (83.3%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8
AnemiaBlood and lymphatic system disorders	0/7	1/19	0/3	0/3	0/4	0/3	0/3	1/7	0/3	1/6
VomitingGastrointestinal disorders	0/7	0/19	0/3	0/3	0/4	0/3	0/3	0/7	0/3	1/6
Scrotal PainReproductive system and breast disorders	0/7	0/19	0/3	0/3	0/4	0/3	0/3	0/7	0/3	1/6
Abdominal PainGastrointestinal disorders	0/7	1/19	0/3	0/3	0/4	0/3	0/3	1/7	0/3	0/6
Generalized Muscle WeaknessMusculoskeletal and connective tissue disorders	0/7	0/19	0/3	0/3	0/4	0/3	0/3	1/7	0/3	0/6
AnorexiaMetabolism and nutrition disorders	0/7	0/19	0/3	0/3	0/4	0/3	0/3	1/7	0/3	0/6
DyspneaRespiratory, thoracic and mediastinal disorders	0/7	0/19	0/3	0/3	0/4	0/3	0/3	1/7	0/3	0/6
ConfusionPsychiatric disorders	0/7	1/19	0/3	0/3	0/4	0/3	0/3	0/7	0/3	0/6
FeverGeneral disorders	0/7	1/19	0/3	0/3	0/4	0/3	0/3	0/7	0/3	0/6
Wound InfectionInjury, poisoning and procedural complications	0/7	1/19	0/3	0/3	0/4	0/3	0/3	0/7	0/3	0/6

Most frequent other events

Showing 10 of 82

Most frequent other events
Event	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8
Alanine aminotransferase increasedInvestigations	1/7	4/19	0/3	0/3	0/4	0/3	1/3	7/7	1/3	0/6
Aspartate aminotransferase increasedInvestigations	0/7	4/19	0/3	0/3	0/4	0/3	2/3	7/7	1/3	1/6
Back PainMusculoskeletal and connective tissue disorders	0/7	1/19	0/3	1/3	3/4	1/3	0/3	0/7	0/3	1/6
Alkaline phosphatase increasedInvestigations	2/7	5/19	2/3	0/3	1/4	0/3	2/3	5/7	1/3	1/6
Abdominal painGastrointestinal disorders	2/7	7/19	2/3	2/3	1/4	2/3	2/3	4/7	0/3	1/6
FatigueGeneral disorders	2/7	6/19	1/3	0/3	1/4	2/3	2/3	4/7	1/3	2/6
ConstipationGastrointestinal disorders	1/7	3/19	1/3	2/3	0/4	0/3	1/3	1/7	0/3	2/6
NauseaGastrointestinal disorders	1/7	5/19	0/3	2/3	1/4	2/3	0/3	2/7	0/3	1/6
AnemiaBlood and lymphatic system disorders	0/7	1/19	0/3	0/3	1/4	0/3	2/3	4/7	0/3	4/6
AnorexiaMetabolism and nutrition disorders	0/7	2/19	0/3	2/3	0/4	0/3	1/3	1/7	0/3	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8	Total
Median	49.02 (44.09 to 77.89)	60.72 (40.98 to 87.84)	54.51 (48.49 to 71.18)	55.5 (42.51 to 71.66)	75.66 (69.04 to 77.85)	48.46 (46.86 to 65.21)	77.73 (68.09 to 79.43)	58.05 (43.96 to 70.74)	69.92 (66.11 to 69.92)	58.94 (50.15 to 74.46)	61.66 (40.98 to 87.84)

Sex: Female, Male
Sex: Female, Male(Participants)	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8	Total
Female	5	14	1	1	2	0	2	3	1	2	31
Male	2	7	2	2	2	3	1	4	2	5	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8	Total
Hispanic or Latino	1	4	0	1	2	1	0	0	1	0	10
Not Hispanic or Latino	6	16	3	2	2	2	3	7	2	7	50
Unknown or Not Reported	0	1	0	0	0	0	0	0	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0
Asian	1	0	0	0	1	0	0	0	1	1	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	1	0	1	1	0	0	2	0	1	6
White	5	14	3	2	2	3	3	5	2	5	44
More than one race	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	6	0	0	0	0	0	0	0	0	7

Region of Enrollment
Region of Enrollment(participants)	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 3	Cohort C: Vitamin C + Y-90 Dose Level 4	Cohort C: Vitamin C + Y-90 Dose Level 5	Cohort C: Vitamin C + Y-90 Dose Level 6	Cohort C: Vitamin C + Y-90 Dose Level 7	Cohort C: Vitamin C + Y-90 Dose Level 8	Total
United States	7	21	3	3	4	3	3	7	3	7	61

Study locations

2 sites

New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York 11215, United States
Weill Cornell Medical College
New York, New York 10065, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 8, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03146962
Lead sponsor: Weill Medical College of Cornell University
Collaborators: Stand Up To Cancer
Responsible party: Sponsor
First posted: May 10, 2017
Start date: Mar 29, 2017
Primary completion: Apr 21, 2023
Completion: Apr 21, 2023
Results posted: May 2, 2024
Last update: May 2, 2024

Study contacts

Manish Shah, MD

principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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