Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441207
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2007-02-26
Brief Title:
Study of High-Dose Intravenous IV Vitamin C Treatment in Patients With Solid Tumors
Sponsor:
Midwestern Regional Medical Center
Organization:
Midwestern Regional Medical Center
Study Overview
Official Title:
A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the safety and tolerability of vitamin C ascorbic acid given by injection into the vein
The second and third purpose of conducting this study is to observe any evidence of tumor response to the vitamin C and compare the level of fatigue weakness pain control ability to do things and quality of life before and after vitamin C is given
The second and third purpose of conducting this study is to observe any evidence of tumor response to the vitamin C and compare the level of fatigue weakness pain control ability to do things and quality of life before and after vitamin C is given
Detailed Description:
Preclinical studies of pharmacologic doses of vitamin C ascorbic acid ascorbate have shown significant anticancer effects in animal models and tissue culture investigations including cytotoxic effects in certain cancer cell lines at micromolar to millimolar concentrations
Early clinical studies have shown that intravenous and oral doses of vitamin C may improve symptoms and prolong survival in terminal cancer patients More recent double-blind placebo-controlled studies have shown that oral adminstration of vitamin C provides no benefit to cancer patients Conversely intravenous vitamin C administration raises plasma concentrations as high as 14 mML and concentrations of 1-5 mML have been found to be selectively cytoxic to tumor cells in vitro
The proposed Phase I trial with vitamin C should achieve millimolar concentrations of vitamin C that have been shown to kill tumor cells in vitro The maximum tolerated dose MTD PK possible drug accumulation with repeated dosing quality of life pain response fatigue status and hints of efficacy in patients with advanced cancer will be examined
Early clinical studies have shown that intravenous and oral doses of vitamin C may improve symptoms and prolong survival in terminal cancer patients More recent double-blind placebo-controlled studies have shown that oral adminstration of vitamin C provides no benefit to cancer patients Conversely intravenous vitamin C administration raises plasma concentrations as high as 14 mML and concentrations of 1-5 mML have been found to be selectively cytoxic to tumor cells in vitro
The proposed Phase I trial with vitamin C should achieve millimolar concentrations of vitamin C that have been shown to kill tumor cells in vitro The maximum tolerated dose MTD PK possible drug accumulation with repeated dosing quality of life pain response fatigue status and hints of efficacy in patients with advanced cancer will be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Ascorbic Acid Injection | None | None | None |