High-dose intravenous vitamin C dosed by how the body clears it for people with advanced solid tumors

Phase I Clinical Study of a New High - Dose Vitamin C Infusion Regimen Based on Pharmacokinetic Characteristics in Combination With Standard Systemic Therapy for Patients With Advanced Malignant Solid Tumors

This trial tests whether giving high-dose IV vitamin C based on each patient's pharmacokinetics can be delivered safely and produce anti-tumor effects in adults with advanced or metastatic solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07121036 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-center interventional trial testing a high-dose intravenous vitamin C regimen tailored to patients' pharmacokinetic characteristics. The primary focus is on safety, tolerability, and pharmacokinetics, with collection of preliminary anti-tumor activity data in adults with advanced or metastatic solid tumors. Eligible participants must have ECOG 0-1, at least one measurable lesion, adequate organ function, no history of calcium oxalate kidney stones, and tumor tissue negative for catalase by immunohistochemistry. Treatments and follow-up visits are conducted at Zhongnan Hospital of Wuhan University.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed advanced or metastatic malignant solid tumors, ECOG performance status 0–1, at least one measurable lesion, adequate bone marrow/liver/kidney/heart function, no history of calcium oxalate kidney stones, and catalase-negative pathology are the intended participants.

Not a fit: Patients with poor performance status (ECOG >1), significant organ dysfunction, a history of calcium oxalate kidney stones, or tumors positive for catalase by immunohistochemistry are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could enable safe achievement of therapeutic plasma vitamin C levels that might slow tumor growth or improve symptoms for some patients.

How similar studies have performed: Previous investigations have produced mixed results—early case reports suggested benefit, a Mayo Clinic randomized trial did not show efficacy, and later work indicates IV high-dose vitamin C reaches much higher plasma levels with phase 1 studies showing relative safety but no consistent proof of clinical benefit.

Eligibility criteria

Inclusion Criteria:

* 1\. Aged 18 - 75 years old, regardless of gender. 2. The subject voluntarily participates, gives full informed consent, signs a written informed consent form, and has good compliance.

  3\. Histologically or cytologically pathologically diagnosed as advanced or metastatic malignant solid tumor.

  4\. Physical function status: Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.

  5\. The patient must have at least one measurable lesion (RECIST 1.1). 6. Sufficient bone marrow, liver, kidney, and heart function were recorded within 7 days before enrollment, and the patient is suitable for routine chemotherapy indicated clinically according to normal care standards.

  7\. No history of calcium oxalate kidney stones. 8. Expected survival ≥ 12 weeks. 9. Pathological immunohistochemistry requires a negative catalase result. 10. Patients who are undergoing systemic anti - tumor treatment and have disease progression can also enter the protocol, continue the same treatment or start a different chemotherapy regimen without interruption.

Exclusion Criteria:

* 1\. Lack of pathological diagnosis of malignant solid tumor. 2. The patient currently has central nervous system (CNS) metastasis or a history of brain metastasis.

  3\. Severe gastrointestinal diseases, including active bleeding. 4. Patients with severe or uncontrolled infections, heart or nervous system diseases.

  5\. Major surgery within 4 weeks or local radiotherapy within 7 days before the administration of the study drug.

  6\. Dementia or severe mental status changes that prevent obtaining informed consent.

  7\. Women of childbearing potential must use an acceptable contraceptive method during the study and must undergo a pregnancy test within 7 days after the first chemotherapy.

  8\. The patient currently has poorly controlled diabetes (fasting blood glucose (FBG) \> 10 mmol/L).

  9\. Glucose - 6 - phosphate dehydrogenase (G6PD) deficiency or hereditary spherocytosis.

  10\. Active pulmonary tuberculosis (TB), patients who are undergoing anti - tuberculosis treatment or have received anti - tuberculosis treatment within 1 year before the first drug administration; patients with positive human immunodeficiency virus (HIV) antibodies; or patients with syphilis infection.

  11\. Active viral hepatitis. If HBsAg (+) and/or HBcAb (+), HBV DNA must be \< 500 IU/mL, and during the study, the patient must continue the original anti - HBV treatment throughout the process or start using entecavir or tenofovir throughout the process. Patients with positive hepatitis C virus (HCV) ribonucleic acid (RNA) must receive antiviral treatment according to local standard treatment guidelines and have liver function within Grade 1 elevation of NCI - CTCAE Version 5.0.

  12\. Any abnormal laboratory values or medical conditions that, in the judgment of the investigator, make the patient unfit for the study.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Lei Yang, Dr

Conditions Vitamin C; High - dose Vitamin C; cancer