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Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease

Phase 2
18 Years
Not Enrolling
Sarcoma, Adenocarcinoma, Carcinoma, Multiple Myeloma, Desmoplastic Small Round Cell Tumor

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Trial Information

Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of treatment

Outcome Description:

Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation

Outcome Time Frame:


Safety Issue:


Principal Investigator

G D Murphy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Situs Cancer Research Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

December 2014

Related Keywords:

  • Sarcoma
  • Adenocarcinoma
  • Carcinoma
  • Multiple Myeloma
  • Desmoplastic Small Round Cell Tumor
  • ascorbic acid
  • vitamin C
  • antioxidants
  • vitamins
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Desmoplastic Small Round Cell Tumor
  • Sarcoma



Situs Cancer Research Center Rogers, Arkansas  72756