Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003498
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Burzynski Research Institute
Organization:
Burzynski Research Institute
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2021-01
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 Non-Hodgkins Lymphoma provide limited benefit to the patient The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Non-Hodgkins Lymphoma
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on patients with Non-Hodgkins Lymphoma
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on patients with Non-Hodgkins Lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkins lymphoma who have failed high-dose chemotherapy and bone marrow transplantation
Describe the response to tolerance to and side effects of this regimen in these patients
Non-Hodgkins Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy Atengenal Astugenal until the maximum tolerated dose is reached Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with Non-Hodgkins Lymphoma 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 Non-Hodgkins Lymphoma
To determine objective response tumor size is measured utilizing physical examination radiologic studies and bone marrow biopsies as necessary performed every 8 weeks for the first two years every 3 months for the third and fourth years every 6 months for the 5th and sixth years and annually thereafter
Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkins lymphoma who have failed high-dose chemotherapy and bone marrow transplantation
Describe the response to tolerance to and side effects of this regimen in these patients
Non-Hodgkins Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy Atengenal Astugenal until the maximum tolerated dose is reached Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with Non-Hodgkins Lymphoma 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 Non-Hodgkins Lymphoma
To determine objective response tumor size is measured utilizing physical examination radiologic studies and bone marrow biopsies as necessary performed every 8 weeks for the first two years every 3 months for the third and fourth years every 6 months for the 5th and sixth years and annually 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-LY-3 | OTHER | Burzynski Research Institute | None |