Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003486
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Patients With Colon Cancer
Sponsor:
Burzynski Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon
Status:
WITHDRAWN
Status Verified Date:
2006-12
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:
RATIONALE Antineoplastons are naturally occurring substances that may also be made in the laboratory Antineoplastons may inhibit the growth of cancer cells
PURPOSE This phase II trial is studying how well antineoplaston therapy works in treating patients with colon cancer
PURPOSE This phase II trial is studying how well antineoplaston therapy works in treating patients with colon cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with adenocarcinoma of the colon by determining the proportion of patients who experience an objective tumor response
Evaluate the adverse effects of and tolerance to this regimen in these patients
OUTLINE This is an open-label study
Patients receive gradually escalating doses of oral antineoplaston A10 and oral antineoplaston AS2-1 6-7 times a day If the patient has not achieved a partial or complete response after 3-4 months of treatment the investigator may discontinue treatment Patients with stable disease may continue to receive treatment until disease progression or unacceptable toxicity is observed
Tumors are measured every 4 months during the first 2 years then every 6 months during years 3 and 4 and yearly during years 5 and 6
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with adenocarcinoma of the colon by determining the proportion of patients who experience an objective tumor response
Evaluate the adverse effects of and tolerance to this regimen in these patients
OUTLINE This is an open-label study
Patients receive gradually escalating doses of oral antineoplaston A10 and oral antineoplaston AS2-1 6-7 times a day If the patient has not achieved a partial or complete response after 3-4 months of treatment the investigator may discontinue treatment Patients with stable disease may continue to receive treatment until disease progression or unacceptable toxicity is observed
Tumors are measured every 4 months during the first 2 years then every 6 months during years 3 and 4 and yearly during years 5 and 6
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066524 | REGISTRY | PDQ Physician Data Query | None |