Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004893
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2000-03-07
Brief Title:
Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Evaluation of Novel Therapeutic Agents Against Breast Cancer An Innovative Randomized Phase II Trial Design
Status:
COMPLETED
Status Verified Date:
2016-07
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 Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill breast cancer cells
PURPOSE Randomized phase II trial to study the effectiveness of interleukin-12 in treating patients who have metastatic or recurrent breast cancer
PURPOSE Randomized phase II trial to study the effectiveness of interleukin-12 in treating patients who have metastatic or recurrent breast cancer
Detailed Description:
OBJECTIVES I Determine the activity of interleukin-12 as defined by the percentage of patients who have not progressed after 6 months of therapy II Compare percentage of patients who have not progressed after six months with or without treatment regimen III Determine time to progression and overall survival in this patient population after this treatment
OUTLINE This is a randomized study Patients are stratified according to disease free interval from primary diagnosis to first metastases less than 3 years vs 3 years and longer estrogen receptor status positive vs negative and disease status complete response partial response detectable disease or stable disease Patients are randomized to one of two treatment arms Arm I Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose Patients receive interleukin-12 subcutaneously twice a week Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed at least every 3 months for 1 year If no progression after 1 year may be followed as needed for new signs or symptoms and survival for 5 years Arm II Patients are observed for 6 months If disease progresses during first 6 months patients may receive interleukin-12 as in arm I Patients without disease progression within first 6 months may also then receive interleukin-12 as in arm I Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed for toxicity only until interleukin-12 is discontinued
OUTLINE This is a randomized study Patients are stratified according to disease free interval from primary diagnosis to first metastases less than 3 years vs 3 years and longer estrogen receptor status positive vs negative and disease status complete response partial response detectable disease or stable disease Patients are randomized to one of two treatment arms Arm I Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose Patients receive interleukin-12 subcutaneously twice a week Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed at least every 3 months for 1 year If no progression after 1 year may be followed as needed for new signs or symptoms and survival for 5 years Arm II Patients are observed for 6 months If disease progresses during first 6 months patients may receive interleukin-12 as in arm I Patients without disease progression within first 6 months may also then receive interleukin-12 as in arm I Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed for toxicity only until interleukin-12 is discontinued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-49806 | None | None | None |
| CDR0000067570 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |