Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003502
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Burzynski Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II III or IV Mantle Cell Lymphoma
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WITHDRAWN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 stage II stage III or stage IV mantle cell lymphoma
PURPOSE This phase II trial is studying how well antineoplaston therapy works in treating patients with stage II stage III or stage IV mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II III or IV mantle cell lymphoma
Evaluate the response to tolerance to and side effects of this regimen in these patients
OUTLINE This is an open-label study
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 intravenously 6 times daily until the maximum tolerated dose is reached Treatment continues in the absence of disease progression or unacceptable toxicity
Tumors are measured every 8 weeks for 6 months every 3 months for 2 years every 6 months for the third and fourth years and then annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II III or IV mantle cell lymphoma
Evaluate the response to tolerance to and side effects of this regimen in these patients
OUTLINE This is an open-label study
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 intravenously 6 times daily until the maximum tolerated dose is reached Treatment continues in the absence of disease progression or unacceptable toxicity
Tumors are measured every 8 weeks for 6 months every 3 months for 2 years every 6 months for the third and fourth years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000066542 | REGISTRY | PDQ Physician Data Query | None |