Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002616
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Biological Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PILOT TRIAL OF INTERLEUKIN-2 WITH G-CSF AS PRIMING THERAPY FOR PERIPHERAL BLOOD STEM CELL HARVESTING IN PATIENTS WITH ADVANCED BREAST CANCER STAMP V HIGH DOSE CHEMOTHERAPY STEM CELL INFUSION AND POST-INFUSION G-CSF AND INTERLEUKIN-2
Status:
UNKNOWN
Status Verified Date:
2000-09
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Peripheral stem cell transplantation combined with biological therapy may be an effective treatment for breast cancer
PURPOSE Phase I trial to study the effectiveness of interleukin-2 with filgrastim to stimulate cell production in treating patients with stage IIIB stage IV metastatic or recurrent breast cancer who will undergo peripheral stem cell transplantation
PURPOSE Phase I trial to study the effectiveness of interleukin-2 with filgrastim to stimulate cell production in treating patients with stage IIIB stage IV metastatic or recurrent breast cancer who will undergo peripheral stem cell transplantation
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of continuous infusion interleukin-2 IL-2 that can be combined with a standard dose of filgrastim G-CSF to stimulate peripheral blood stem cells PBSC for harvest in patients with advanced breast cancer II Assess PBSC engraftment following high dose cyclophosphamide thiotepa and carboplatin the STAMP V regimen supported by G-CSF or IL-2G-CSF hematopoietic support in patients who underwent the same pretransplant PBSC stimulation III Characterize the toxic effects of combined IL-2 and G-CSF IV Compare immune function changes following IL-2G-CSF and G-CSF alone by assessing expression of CD56CD56-bright CD3 and CD25 natural killer cell and lymphokine activated killer cell activity T-cell responses TT HER2neu and serum levels of interleukin-6 tumor necrosis factor and G-CSF V Compare the effects on the expression of circulating hematopoietic progenitor cells CD34 CFU-GM and BFU-GM of a range of IL-2 doses when combined with G-CSF to those achieved with G-CSF alone VI Compare the time to neutrophil and platelet recovery requirements for red blood cell and platelet transfusion and time to hospital discharge in patients receiving IL-2G-CSF-primed vs G-CSF-primed PBSC following STAMP V chemotherapy VII Compare the feasibility toxicity and hematologic and immunologic effects of post-PBSC infusion of IL-2G-CSF vs G-CSF alone VIII Assess the response rate duration of response and disease free interval of patients with advanced breast cancer treated with STAMP V with PBSC rescue IX Assess the presence of cytokeratin as a marker of minimum residual disease when measured in blood and marrow by polymerase chain reaction during and following treatment
OUTLINE Patients are assigned to 1 of 4 treatment groups for peripheral blood stem cell stimulation priming and for therapy after stem cell transplantation All patients receive priming therapy with filgrastim G-CSF alone or with interleukin-2 IL-2 then have stem cells harvested Patients with adequate harvest receive high dose cyclophosphamide thiotepa and carboplatin STAMP V followed by stem cell rescue with subsequent G-CSF with or without IL-2 as follows Arm I receives G-CSF alone for priming and following stem cell transplant Arm II receives G-CSF priming alone and G-CSFIL-2 following transplant Arm III receives various doses of G-CSFIL-2 priming and G-CSF following transplant Arm IV receives various levels of G-CSFIL-2 priming and fixed doses of G-CSFIL-2 following transplant Cohorts of 3-6 patients each are treated on each treatment arm and at escalating doses of IL-2 The maximum tolerated dose is defined as the dose at which less than 2 of 6 patients experience dose limiting toxicity Patients are followed for disease progression and survival
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study over 18-24 months a maximum of 12 patients will receive G-CSF priming alone 6 without and 6 with post-PBSC IL-2
OUTLINE Patients are assigned to 1 of 4 treatment groups for peripheral blood stem cell stimulation priming and for therapy after stem cell transplantation All patients receive priming therapy with filgrastim G-CSF alone or with interleukin-2 IL-2 then have stem cells harvested Patients with adequate harvest receive high dose cyclophosphamide thiotepa and carboplatin STAMP V followed by stem cell rescue with subsequent G-CSF with or without IL-2 as follows Arm I receives G-CSF alone for priming and following stem cell transplant Arm II receives G-CSF priming alone and G-CSFIL-2 following transplant Arm III receives various doses of G-CSFIL-2 priming and G-CSF following transplant Arm IV receives various levels of G-CSFIL-2 priming and fixed doses of G-CSFIL-2 following transplant Cohorts of 3-6 patients each are treated on each treatment arm and at escalating doses of IL-2 The maximum tolerated dose is defined as the dose at which less than 2 of 6 patients experience dose limiting toxicity Patients are followed for disease progression and survival
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study over 18-24 months a maximum of 12 patients will receive G-CSF priming alone 6 without and 6 with post-PBSC IL-2
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 |
|---|---|---|---|
| LUMC-6728 | None | None | None |
| NCI-V94-0573 | None | None | None |
| UIC-95-1011 | None | None | None |