Study of High-Dose Intravenous (IV) Vitamin C Treatment in Patients With Solid Tumors

NCT00441207 | Completed Phase 1 DMC

• 2 other identifiers: CTCA 06-04Ascorbic Acid Injection
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the safety and tolerability of vitamin C (ascorbic acid) given by injection into the vein. The second and third purpose of conducting this study is to observe any evidence of tumor response to the vitamin C and compare the level of fatigue (weakness), pain control, ability to do things, and quality of life, before and after vitamin C is given.

Conditions

Cancer

Keywords

IV Ascorbic Acid; IV Vitamin C; Cancer; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy

  1-1/2 years

• Evaluate the pharmacokinetic profile of IV vitamin C at varying doses

  1-1/2 years

Secondary Outcomes (3)

• Determine if vitamin C accumulates with repeated daily therapy by measuring peak and nadir levels

  1 year

• Evaluate patient quality of life

  Duration of Study

• Observe patients for clinical and radiological evidence of anti-tumor activity at the end of treatment

  Duration of Study

Interventions

Ascorbic Acid DRUG

Delivered via IV Infusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary histological diagnosis of advanced solid tumors (stage 3 and 4) and measurable disease.
• Disease must have progressed for which no available treatment provides clinical benefit.
• years of age or older.
• No scheduled cancer therapy (chemotherapy, hormonal therapy, immune therapy, or radiation therapy) for three months after study entry, and the subject must have had their last therapy at least four (4) weeks prior to entry to this study.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Informed Consent - The patient must be willing and able to sign the informed consent prior to the start of the trial.
• Willingness to comply with the weekly phone calls between office visits.
• Willingness to undergo central line placement (e.g., port-a-catheter, central venous catheter, percutaneously inserted central catheter \[PICC\] line placement) and able to manage care of the entry site safely.
• Patients must be able to take food orally or have peg tube for feeding.
• Life expectancy of at least 3 months.

You may not qualify if:

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication)
• Renal insufficiency as evidenced by serum creatinine of ≥ 1.3 mg/dl or evidence of oxalosis by urinalysis.
• Chronic hemodialysis.
• Iron overload (a ferritin \> 500 ng/ml).
• Wilson's disease.
• Compromised liver function with evidence of complete biliary obstruction or have a serum bilirubin of 2.0 or liver function tests (AST \> 63, ALT \> 95) exceeding 1.5 x the upper limit of normal.
• Pregnant or lactating female.
• Current tobacco use.
• Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
• Aspirin use exceeding 325 mg per day.
• Acetaminophen use exceeding 2 g per day.
• Brain metastases that have not responded to therapy.

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

Study Sites (1)

CTCA @ Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Christopher Lis

  Midwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DO

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 28, 2007
• Study Start: August 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)