Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003199
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial for Patients With Inflammatory Stage IIIB and Responsive Metastatic Stage IV Breast Cancer Using Busulfan Melphalan and Thiotepa Followed by Autologous or Syngeneic PBSC Rescue and 12 Weeks of Post-Engraftment Immunotherapy With Low-Dose IL-2 and GM-CSF
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer Drugs used in chemotherapy such as busulfan melphalan and thiotepa work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy This may allow more chemotherapy to be given so that more tumor cells are killed Aldesleukin may stimulate the white blood cells to kill breast cancer cells Giving aldesleukin together with sargramostim may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the event-free survival and survival of patients treated for inflammatory Stage IIIb and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF
SECONDARY OBJECTIVES
II To determine the toxicity of a combination of low-dose IL-2 and GM-CSF in patients following HDC with BUMELTT and PBSC support
OUTLINE
PREPARATIVE REGIMEN Patients receive busulfan orally PO once every 6 hours on days -8 -7 and -6 melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2
TRANSPLANTATION Patients undergo autologous peripheral blood stem cell infusion on day 0
POST-TRANSPLANT THERAPY All patients receive tamoxifen citrate PO once daily beginning prior to aldesleukin IL-2 and sargramostim GM-CSF therapy and continuing for 5 years or until relapse estrogen receptor ER- or progesterone receptor PR-positive patients OR until completion of IL-2GM-CSF therapy ER-negative or PR-negative patients Eligible patients receive IL-2 subcutaneously SC daily and GM-CSF SC 3 times weekly for 12 weeks beginning 30-100 days after transplantation Patients may receive radiotherapy after completion of IL-2GM-CSF treatment if no prior radiotherapy was given before transplantation
Stage IV patients not receiving IL-2GM-CSF therapy who received tamoxifen citrate as part of adjuvant therapy and subsequently failed receive oral anastrozole once daily for 5 years or until progression instead of tamoxifen
For postmenopausal patients the choice and duration of hormonal therapy given in addition to or an alternative to tamoxifen therapy will be at the physicians discretion
Patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To determine the event-free survival and survival of patients treated for inflammatory Stage IIIb and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF
SECONDARY OBJECTIVES
II To determine the toxicity of a combination of low-dose IL-2 and GM-CSF in patients following HDC with BUMELTT and PBSC support
OUTLINE
PREPARATIVE REGIMEN Patients receive busulfan orally PO once every 6 hours on days -8 -7 and -6 melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2
TRANSPLANTATION Patients undergo autologous peripheral blood stem cell infusion on day 0
POST-TRANSPLANT THERAPY All patients receive tamoxifen citrate PO once daily beginning prior to aldesleukin IL-2 and sargramostim GM-CSF therapy and continuing for 5 years or until relapse estrogen receptor ER- or progesterone receptor PR-positive patients OR until completion of IL-2GM-CSF therapy ER-negative or PR-negative patients Eligible patients receive IL-2 subcutaneously SC daily and GM-CSF SC 3 times weekly for 12 weeks beginning 30-100 days after transplantation Patients may receive radiotherapy after completion of IL-2GM-CSF treatment if no prior radiotherapy was given before transplantation
Stage IV patients not receiving IL-2GM-CSF therapy who received tamoxifen citrate as part of adjuvant therapy and subsequently failed receive oral anastrozole once daily for 5 years or until progression instead of tamoxifen
For postmenopausal patients the choice and duration of hormonal therapy given in addition to or an alternative to tamoxifen therapy will be at the physicians discretion
Patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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-2010-00728 | REGISTRY | CTRP Clinical Trial Reporting Program | None |