Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease
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|ClinicalTrials.gov Identifier: NCT01125449|
Recruitment Status : Suspended (Awaiting response from FDA as to status of parenteral ascorbic acid manufactured by Bioniche (Ireland).)
First Posted : May 18, 2010
Last Update Posted : August 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Adenocarcinoma Carcinoma Multiple Myeloma Desmoplastic Small Round Cell Tumor||Drug: Ascorbic acid (vitamin C)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2014|
Intravenous IVC Intervention
Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.
Drug: Ascorbic acid (vitamin C)
Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.
Other Name: Bioniche ascorbic acid, parenteral, 500mg/ml
- Efficacy of treatment [ Time Frame: 12-weeks ]Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation
- Quality of Life [ Time Frame: 12-weeks ]Quality of life during treatment will be measured using FACT questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125449
|United States, Arkansas|
|Situs Cancer Research Center|
|Rogers, Arkansas, United States, 72756|
|Principal Investigator:||G D Murphy, MD||Situs Cancer Research Center|
|Study Director:||J Bolt, PhD||Situs Cancer Research Center|