Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081809
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2004-04-20
Brief Title:
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
Sponsor:
Agenus Inc
Organization:
Agenus Inc
Study Overview
Official Title:
A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex HSPPC-96
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Primary Objectives
To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma The efficacy endpoints are
the rate of complete and partial responses
the time to progression
Secondary Objectives
To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex HSPPC-96 administered intradermally once weekly for four consecutive weeks followed by HSPPC-96 administered once every two weeks
To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens
To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient
To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma
To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma The efficacy endpoints are
the rate of complete and partial responses
the time to progression
Secondary Objectives
To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex HSPPC-96 administered intradermally once weekly for four consecutive weeks followed by HSPPC-96 administered once every two weeks
To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens
To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient
To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma
Detailed Description:
None
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 |
|---|---|---|---|
| MDACC Protocol ID99-354 | None | None | None |