Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003516
Status:
TERMINATED
Last Update Posted:
2018-02-05
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Sponsor:
Burzynski Research Institute
Organization:
Burzynski Research Institute
Study Overview
Official Title:
Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable Stage C or D Adenocarcinoma of the Prostate
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Current therapies for Stage III or Stage IV Prostate Cancer provide very limited benefit to the patient The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage III or Stage IV Prostate Cancer
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer
Detailed Description:
Stage III or Stage IV Prostate Cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day Treatment continues in the absence of disease progression or unacceptable toxicity
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer as measured by an objective response to therapy complete response partial response or stable disease
To determine the safety and tolerance of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer
To determine objective response tumor size is measured utilizing MRI scans which are performed every 4 months for 2 years every 6 months for 2 years and then annually for 2 years thereafter
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer as measured by an objective response to therapy complete response partial response or stable disease
To determine the safety and tolerance of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer
To determine objective response tumor size is measured utilizing MRI scans which are performed every 4 months for 2 years every 6 months for 2 years and then annually for 2 years thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| BC-PR-5 | OTHER | Burzynski Research Institute | None |