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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sarcoma, Adenocarcinoma, Carcinoma, Multiple Myeloma, Desmoplastic Small Round Cell Tumor

Intervention / Treatment
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* Drug: Ascorbic acid (vitamin C)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravenous IVC Intervention<br>Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min. | Drug: Ascorbic acid (vitamin C)<br>* Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.<br>* Other names: Bioniche ascorbic acid, parenteral, 500mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment | Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life during treatment will be measured using FACT questionnaires. | 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascorbic acid, vitamin C, antioxidants, vitamins