Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036426
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-05-09
Brief Title:
Idiotype Vaccine for Low-Grade Non-Hodgkins Lymphoma
Sponsor:
Favrille
Organization:
Favrille
Study Overview
Official Title:
Phase II Study of FavId Tumor-Specific Idiotype-KLH and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine if an idiotype vaccine made from a patients lymphoma that has returned after chemotherapy andor rituximab would be able to shrink their tumor
Detailed Description:
The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma B-cell malignancies express a unique antigen the immunoglobulin idiotype Id on their surface Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein No normal B-cells possess that Id on their cell surface Hence Id protein should serve as an ideal target for individualized active immune therapy of NHL Many of the antigens expressed by tumors including Id are only weak immunogens To augment the immune response against Id the Id protein must be chemically coupled to a strongly immunogenic protein Keyhole limpet hemocyanin KLH is a commonly used protein carrier capable of augmenting the bodys immune reaction against Id protein While initial studies reported a predominately humoral antibody response cellular immunity T-cells also plays a critical role in anti-tumor immunity GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation
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