Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014573
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
2001-04-10
Brief Title:
Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial Of High Dose Cyclophosphamide Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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 bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Vaccines made from a persons white blood cells and tumor cells may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer
Detailed Description:
OBJECTIVES
Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim GM-CSF followed by high-dose chemotherapy with cisplatin cyclophosphamide and carmustine autologous bone marrow or peripheral blood stem cell transplantation and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors
Determine the safety and toxicity of this regimen in these patients
Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen
OUTLINE After partial surgical resection of tumor patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1 Patients also receive filgrastim G-CSF subcutaneously SC daily beginning on day 3 and continuing until peripheral blood stem cell PBSC or bone marrow collection is completed
After the collection of PBSC or bone marrow patients receive autologous tumor cell vaccine and sargramostim GM-CSF SC once every 2 weeks for up to 5 vaccinations Two weeks after the last vaccination patients undergo a second leukapheresis to collect lymphocytes
After completion of the second leukapheresis patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5 cyclophosphamide IV over 1 hour on days -5 -4 and -3 and carmustine IV over 2 hours on day -2 Patients undergo autologous bone marrow or PBSC transplantation on day 0 Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover
Approximately 12 weeks after bone marrow or PBSC transplantation patients receive autologous lymphocytes IV over 2-5 hours Patients also receive interleukin-2 IV once every other day for 10 days
Patients are followed at 18 24 36 40 and 52 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim GM-CSF followed by high-dose chemotherapy with cisplatin cyclophosphamide and carmustine autologous bone marrow or peripheral blood stem cell transplantation and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors
Determine the safety and toxicity of this regimen in these patients
Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen
OUTLINE After partial surgical resection of tumor patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1 Patients also receive filgrastim G-CSF subcutaneously SC daily beginning on day 3 and continuing until peripheral blood stem cell PBSC or bone marrow collection is completed
After the collection of PBSC or bone marrow patients receive autologous tumor cell vaccine and sargramostim GM-CSF SC once every 2 weeks for up to 5 vaccinations Two weeks after the last vaccination patients undergo a second leukapheresis to collect lymphocytes
After completion of the second leukapheresis patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5 cyclophosphamide IV over 1 hour on days -5 -4 and -3 and carmustine IV over 2 hours on day -2 Patients undergo autologous bone marrow or PBSC transplantation on day 0 Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover
Approximately 12 weeks after bone marrow or PBSC transplantation patients receive autologous lymphocytes IV over 2-5 hours Patients also receive interleukin-2 IV once every other day for 10 days
Patients are followed at 18 24 36 40 and 52 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-1654 | None | None | None |
| WSU-07-92-98-P04-FB | OTHER | None | None |
| NCI-G01-1937 | Other Identifier | Wayne State University - Human Investigation Committee | httpsreporternihgovquickSearchP30CA022453 |