Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101101
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2005-01-07
Brief Title:
Universal Granulocyte Macrophage-colony Stimulating Factor GM-CSF-Producing and GMCD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line GMCD40L in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-08
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 Vaccines made from gene-modified cells and a persons cancer cells may make the body build an effective immune response to kill cancer cells Interleukin-2 IL-2 may stimulate the white blood cells to kill cancer cells Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells Giving vaccine therapy together with IL-2 after combination chemotherapy may be a more effective treatment for mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving vaccine therapy together with IL-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II stage III or stage IV mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving vaccine therapy together with IL-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II stage III or stage IV mantle cell lymphoma
Detailed Description:
Patients were treated with 3-6 cycles of chemotherapy - rituximab with type and duration at the discretion of the individual clinician Evaluation for response was performed 1 month after completing chemotherapy and included computed tomography CT scan bone marrow biopsy endoscopy and colonoscopy Minimal residual disease MRD was assessed qualitatively on bone marrow specimens using polymerase chain reaction PCR with standardized primers for evaluation for B-cell receptor gene rearrangement Responses were defined according to revised Cheson criteria Patients with successful lymph node harvest who had obtained complete or partial response could proceed to bystander vaccination
The GMCD40L bystander vaccine administered intradermally into the bilateral axillary and inguinal nodal basins via eight separate injections 0125 ml injection Low dose IL-2 05 x 106 units was given subcutaneously twice daily for 14 days following vaccination Patients were restaged with CT andor CTPET and bone marrow biopsy every 6 months beginning from the last date of chemotherapy Follow-up bone marrow biopsy evaluation included an assessment for MRD as described above Patients without disease progression or toxicity attributable to the vaccine were eligible for 4 monthly booster vaccines at 12 months and 24 months
The GMCD40L bystander vaccine administered intradermally into the bilateral axillary and inguinal nodal basins via eight separate injections 0125 ml injection Low dose IL-2 05 x 106 units was given subcutaneously twice daily for 14 days following vaccination Patients were restaged with CT andor CTPET and bone marrow biopsy every 6 months beginning from the last date of chemotherapy Follow-up bone marrow biopsy evaluation included an assessment for MRD as described above Patients without disease progression or toxicity attributable to the vaccine were eligible for 4 monthly booster vaccines at 12 months and 24 months
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 |
|---|---|---|---|
| 0406-654 | OTHER | OBA | None |