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

Situs Cancer Research Center

Status and phase

Withdrawn

Phase 2

Conditions

Multiple Myeloma

Sarcoma

Desmoplastic Small Round Cell Tumor

Carcinoma

Adenocarcinoma

Treatments

Drug: Ascorbic acid (vitamin C)

Study type

Interventional

Funder types

Other

Identifiers

NCT01125449

L500HD

Details and patient eligibility

About

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.

Full description

Ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while sparing normal cells from its peroxidative effects. This study will examine the effect, if any, of the drug when dosed in patients at a level sufficient to achieve transient serum states of 400mg/dl. Safety of the drug has been shown in a Phase I study when dosed as high as 1.5gm/kg. Patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated for response using RECIST criteria. Patients showing stable disease or objective response will remain on study for up to one year or until absence of measurable disease or disease progression.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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