Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027937
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2001-12-07
Brief Title:
Combination Chemotherapy Peripheral Stem Cell Transplantation and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma
Status:
COMPLETED
Status Verified Date:
2010-05
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Biological therapies such as interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy peripheral stem cell transplantation and interleukin-2 in treating patients who have solid tumors or lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy peripheral stem cell transplantation and interleukin-2 in treating patients who have solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Determine the toxicity of sargramostim GM-CSF and filgrastim G-CSF-mobilized interleukin-2IL-2-incubated autologous peripheral blood stem cells and sequential IL-2 in patients with solid tumors or lymphoma
Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF to mobilize adequate numbers of CD34 cells and immune cells in these patients
Determine the time to neutrophil and platelet engraftment in patients treated with this regimen
Determine the overall and disease-free survival of patients treated with this regimen
OUTLINE Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2 Patients also receive sargramostim GM-CSF subcutaneously SC alone on days 3-9 and GM-CSF and filgrastim G-CSF SC beginning on day 10 and continuing until leukapheresis is completed
Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6 melphalan IV on days -5 and -4 and thiotepa IV on days -3 and -2 Autologous peripheral blood stem cells PBSC are treated ex vivo with interleukin-2 IL-2 on day -1 Patients undergo IL-2-treated autologous PBSC transplantation on day 0
Beginning 4 hours after PBSC transplantation patients receive IL-2 IV continuously for 5 days IL-2 therapy repeats every 7 days for 4 courses
Patients are followed on days 60-80 every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 3 years
Determine the toxicity of sargramostim GM-CSF and filgrastim G-CSF-mobilized interleukin-2IL-2-incubated autologous peripheral blood stem cells and sequential IL-2 in patients with solid tumors or lymphoma
Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF to mobilize adequate numbers of CD34 cells and immune cells in these patients
Determine the time to neutrophil and platelet engraftment in patients treated with this regimen
Determine the overall and disease-free survival of patients treated with this regimen
OUTLINE Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2 Patients also receive sargramostim GM-CSF subcutaneously SC alone on days 3-9 and GM-CSF and filgrastim G-CSF SC beginning on day 10 and continuing until leukapheresis is completed
Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6 melphalan IV on days -5 and -4 and thiotepa IV on days -3 and -2 Autologous peripheral blood stem cells PBSC are treated ex vivo with interleukin-2 IL-2 on day -1 Patients undergo IL-2-treated autologous PBSC transplantation on day 0
Beginning 4 hours after PBSC transplantation patients receive IL-2 IV continuously for 5 days IL-2 therapy repeats every 7 days for 4 courses
Patients are followed on days 60-80 every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| FHCRC-159500 | None | None | None |
| IMMUNEX-FHCRC-159500 | None | None | None |
| NCI-G01-2037 | None | None | None |
| CDR0000069095 | REGISTRY | PDQ | None |