Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003536
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Sponsor:
Burzynski Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
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WITHDRAWN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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Antineoplastons are naturally occurring substances that may also be made in the laboratory Antineoplastons may inhibit the growth of cancer cells It is not yet known whether giving antineoplastons with chemotherapy is more effective than chemotherapy alone in treating women with refractory breast cancer
PURPOSE This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer
PURPOSE This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer
Detailed Description:
OBJECTIVES
Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate alone in terms of objective tumor response in women with advanced breast cancer
Compare the adverse effects of and tolerance to these regimens in these patients
OUTLINE This is a randomized study
Arm I Patients receive gradually escalating doses of oral antineoplaston A10 capsules 7 times daily until the maximum tolerated dose is reached followed by oral methotrexate capsules 2 to 3 times per day in five days on and five days off courses Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral methotrexate alone on the same schedule as in arm I
Tumors are measured every 4 months for 2 years every 6 months for years 3 and 4 and then annually for years 5 and 6
PROJECTED ACCRUAL A total of 30-70 patients will be accrued for this study within at least 12 months
Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate alone in terms of objective tumor response in women with advanced breast cancer
Compare the adverse effects of and tolerance to these regimens in these patients
OUTLINE This is a randomized study
Arm I Patients receive gradually escalating doses of oral antineoplaston A10 capsules 7 times daily until the maximum tolerated dose is reached followed by oral methotrexate capsules 2 to 3 times per day in five days on and five days off courses Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral methotrexate alone on the same schedule as in arm I
Tumors are measured every 4 months for 2 years every 6 months for years 3 and 4 and then annually for years 5 and 6
PROJECTED ACCRUAL A total of 30-70 patients will be accrued for this study within at least 12 months
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 |
|---|---|---|---|
| CDR0000066584 | REGISTRY | PDQ Physician Data Query | None |