Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003412
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Post Transplant rhIL-12 High Dose Cyclophosphamide Thiotepa and Carboplatin in the Treatment of Metastatic Breast Carcinoma
Status:
UNKNOWN
Status Verified Date:
2001-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Phase I trial to study the effectiveness of interleukin-12 in treating women with metastatic breast cancer who have received high-dose chemotherapy and peripheral stem cell transplantation
PURPOSE Phase I trial to study the effectiveness of interleukin-12 in treating women with metastatic breast cancer who have received high-dose chemotherapy and peripheral stem cell transplantation
Detailed Description:
OBJECTIVES I Determine the toxic effect profile and maximum tolerated dose of interleukin-12 rhIL-12 in women with advanced breast cancer who have undergone high dose chemotherapy with stem cell rescue II Determine the effect of rhIL-12 on cellular and humoral immune systems following high dose chemotherapy III Explore the effect on treatment failure of rhIL-12 after high dose chemotherapy with stem cell rescue
OUTLINE This is a dose escalation study of interleukin-12 rhIL-12 RhIL-12 therapy begins 3-5 weeks after discharge from the chemotherapystem cell transplant hospitalization or 2-3 weeks after completion of posttransplant radiation Patients receive rhIL-12 subcutaneously twice a week for 12 consecutive weeks Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at each dose level of rhIL-12 The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity Patients are followed every 2 months after treatment
PROJECTED ACCRUAL Approximately 6-35 patients will be accrued for this study within 1-2 years
OUTLINE This is a dose escalation study of interleukin-12 rhIL-12 RhIL-12 therapy begins 3-5 weeks after discharge from the chemotherapystem cell transplant hospitalization or 2-3 weeks after completion of posttransplant radiation Patients receive rhIL-12 subcutaneously twice a week for 12 consecutive weeks Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at each dose level of rhIL-12 The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity Patients are followed every 2 months after treatment
PROJECTED ACCRUAL Approximately 6-35 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| NCI-T98-0002 | None | None | None |
| BIH-L97-0252 | None | None | None |