Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134082
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2005-08-22
Brief Title:
Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Pilot Study of Rituximab High Dose Cyclophosphamide and GM-CSF Based Immunotherapy for Relapsed Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2019-02
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 Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Vaccines made from another persons cancer cells may help the body build an effective immune response to kill cancer cells Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells
PURPOSE This phase III trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma
PURPOSE This phase III trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of rituximab and high-dose cyclophosphamide followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkins tumor antigens and sargramostim GM-CSF KGEL vaccine as salvage therapy in patients with relapsed Hodgkin lymphoma
Determine the immunologic response to this vaccine in these patients
Secondary
Determine the 3-year relapse-free and overall survival of patients treated with this regimen
Determine the patterns of cellular immune reconstitution in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive rituximab IV on days -10 and -7 and then on days 29 36 43 and 50 weeks 4-7 and high-dose transplant-dose cyclophosphamide IV on days -3 to 0 without stem cell rescue Patients receive filgrastim G-CSF subcutaneously once daily beginning on day 6 and continuing until blood counts recover Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkins tumor antigens and sargramostim GM-CSF KGEL vaccine intradermally on day 1 and weeks 4 8 12 16 and 24
After completion of high-dose cyclophosphamide patients are followed every 3 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
Primary
Determine the safety and tolerability of rituximab and high-dose cyclophosphamide followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkins tumor antigens and sargramostim GM-CSF KGEL vaccine as salvage therapy in patients with relapsed Hodgkin lymphoma
Determine the immunologic response to this vaccine in these patients
Secondary
Determine the 3-year relapse-free and overall survival of patients treated with this regimen
Determine the patterns of cellular immune reconstitution in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive rituximab IV on days -10 and -7 and then on days 29 36 43 and 50 weeks 4-7 and high-dose transplant-dose cyclophosphamide IV on days -3 to 0 without stem cell rescue Patients receive filgrastim G-CSF subcutaneously once daily beginning on day 6 and continuing until blood counts recover Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkins tumor antigens and sargramostim GM-CSF KGEL vaccine intradermally on day 1 and weeks 4 8 12 16 and 24
After completion of high-dose cyclophosphamide patients are followed every 3 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 25 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 |
|---|---|---|---|
| NA_00035358 | OTHER | JHMIRB | httpsreporternihgovquickSearchP30CA006973 |
| P50CA096888 | NIH | None | None |
| P30CA006973 | NIH | None | None |