Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003412|
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 31, 2004
Last Update Posted : September 17, 2013
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: recombinant interleukin-12||Phase 1|
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 chemotherapy/stem 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||Phase I Study of Post Transplant rhIL-12 High Dose Cyclophosphamide, Thiotepa, and Carboplatin in the Treatment of Metastatic Breast Carcinoma|
|Study Start Date :||June 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003412
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||David Avigan, MD||Beth Israel Deaconess Medical Center|