Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006478
Status:
TERMINATED
Last Update Posted:
2023-09-18
First Post:
2000-11-06
Brief Title:
Vaccine Therapy Following Chemotherapy Peripheral Stem Cell Transplantation in Treating Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Genitope suspend drug development by decision made by the FDA March 6 2008
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a persons cancer cells may make the body build an immune response to kill cancer cells Vaccine therapy may be an effective treatment for non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the humoral and cellular immune responses in patients with follicular non-Hodgkins lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim GM-CSF
Determine the safety and toxicity of this regimen in these patients in the post-transplant setting
Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines
OUTLINE Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously SC on day 1 Sargramostim GM-CSF SC is administered on days 1-4 Treatment repeats every 4 weeks for 4 doses followed 12 weeks later by the fifth and final dose
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the humoral and cellular immune responses in patients with follicular non-Hodgkins lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim GM-CSF
Determine the safety and toxicity of this regimen in these patients in the post-transplant setting
Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines
OUTLINE Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously SC on day 1 Sargramostim GM-CSF SC is administered on days 1-4 Treatment repeats every 4 weeks for 4 doses followed 12 weeks later by the fifth and final dose
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| GENITOPE-IND-8294 | OTHER_GRANT | Genitope Corporation | None |
| 37-7109-2007-001 | OTHER_GRANT | None | None |