Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003517
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
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:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate
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WITHDRAWN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 III or stage IV prostate cancer
PURPOSE This phase II trial is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized regional or metastatic adenocarcinoma of the prostate 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 antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity Concurrently patients continue hormonal therapy with flutamide leuprolide or bicalutamide at the same dose as before beginning antineoplaston therapy
Tumors are measured every 4 months for 2 years every 6 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized regional or metastatic adenocarcinoma of the prostate 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 antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity Concurrently patients continue hormonal therapy with flutamide leuprolide or bicalutamide at the same dose as before beginning antineoplaston therapy
Tumors are measured every 4 months for 2 years every 6 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| CDR0000066560 | REGISTRY | PDQ Physician Data Query | None |