Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease

• Status: Suspended
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Situs Cancer Research Center
• Treatments: Ascorbic Acid; Vitamins

Criteria

Inclusion Criteria:

• 18 years or older at time of entry on study

• Disease extent confirmed and documented by CT scan within 45 days of entry on study

• normal glucose 6-phosphate dehydrogenase

• no current calcium oxalate nephrolithiasis with the potential to reduce urinary flow

• ability to understand the informed consent process and to give informed consent to treatment

• measurable solid tumor neoplastic disease (using RECIST criteria)

• life expectancy greater than 8-weeks

• will agree to undergo central line placement (examples are: port-a-catheter, central venous catheter, percutaneously inserted central catheter [PICC] line placement). Patient or regular caregiver must be able to maintain flush central line as directed by study physician. (Study center will provide periodic site dressing changes as required)

• Failed curative therapy or patient ineligible for definitive curative therapy

• Karnofsky performance status of at least 40

Exclusion Criteria:

• any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study

• use of any nicotine product including nicotine patches/gum

• unstable angina not well managed with medication

• history of calcium oxalate stone formation

• pregnancy or nursing of an infant

• any psychiatric disorder by history or examination that would prevent completion of the study