Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343447
Status:
WITHDRAWN
Last Update Posted:
2012-05-03
First Post:
2006-06-22
Brief Title:
Cyclophosphamide and Rituximab Followed By Vaccine Therapy in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Randomized Trial of Early Versus Late Vaccination in Patients With High Risk CLL
Status:
WITHDRAWN
Status Verified Date:
2012-05
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 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 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 Vaccines may help the body build an effective immune response to kill cancer cells Giving cyclophosphamide and rituximab together with vaccine therapy may kill more cancer cells
PURPOSE This randomized phase II trial is studying cyclophosphamide and rituximab followed by two different schedules of vaccine therapy to compare how well they work in treating patients with chronic lymphocytic leukemia
PURPOSE This randomized phase II trial is studying cyclophosphamide and rituximab followed by two different schedules of vaccine therapy to compare how well they work in treating patients with chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the efficacy and toxicity of cyclophosphamide and rituximab in patients with previously untreated high-risk chronic lymphocytic leukemia
Determine preliminarily the efficacy and toxicity of early vs delayed administration of vaccine therapy comprising KGEL and autologous tumor cells after cyclophosphamide and rituximab in these patients
Compare the magnitude of the T-cell response to early vs delayed administration of this vaccine after rituximab and cyclophosphamide and correlate these responses with the extent of immune reconstruction
OUTLINE This is a randomized phase II study for patients with asymptomatic or minimally symptomatic untreated CLL with poor-risk features
Patients undergo peripheral blood collection for vaccine production Patients then receive rituximab IV over at least 4 hours on days 1 and 2 in course 1 and on day 1 only in subsequent courses and cyclophosphamide IV over 1 hour on day 1 Treatment with rituximab and cyclophosphamide repeats every 21 days for up to 6 cycles in the absence of disease progression Patients undergo evaluation 4 weeks after completion of rituximab and cyclophosphamide Patients achieving partial or complete response are randomized to 1 of 2 vaccine treatment arms
Arm I early administration Beginning 2 weeks after evaluation patients receive vaccine therapy comprising an autologous tumor admixed with an allogeneic vaccine KGEL that produces sargramostim GM-CSF and autologous tumor cells intradermally Treatment repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity
Arm II late administration Beginning 20 weeks after evaluation patients receive vaccine therapy comprising KGEL and autologous tumor cells intradermally Treatment repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Determine the efficacy and toxicity of cyclophosphamide and rituximab in patients with previously untreated high-risk chronic lymphocytic leukemia
Determine preliminarily the efficacy and toxicity of early vs delayed administration of vaccine therapy comprising KGEL and autologous tumor cells after cyclophosphamide and rituximab in these patients
Compare the magnitude of the T-cell response to early vs delayed administration of this vaccine after rituximab and cyclophosphamide and correlate these responses with the extent of immune reconstruction
OUTLINE This is a randomized phase II study for patients with asymptomatic or minimally symptomatic untreated CLL with poor-risk features
Patients undergo peripheral blood collection for vaccine production Patients then receive rituximab IV over at least 4 hours on days 1 and 2 in course 1 and on day 1 only in subsequent courses and cyclophosphamide IV over 1 hour on day 1 Treatment with rituximab and cyclophosphamide repeats every 21 days for up to 6 cycles in the absence of disease progression Patients undergo evaluation 4 weeks after completion of rituximab and cyclophosphamide Patients achieving partial or complete response are randomized to 1 of 2 vaccine treatment arms
Arm I early administration Beginning 2 weeks after evaluation patients receive vaccine therapy comprising an autologous tumor admixed with an allogeneic vaccine KGEL that produces sargramostim GM-CSF and autologous tumor cells intradermally Treatment repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity
Arm II late administration Beginning 20 weeks after evaluation patients receive vaccine therapy comprising KGEL and autologous tumor cells intradermally Treatment repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| JHOC-NA_00000982 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J0579 | None | None | None |