Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003185
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Patients With Glioblastoma Multiforme
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized Ex Vivo Activated T Lymphocytes
Status:
COMPLETED
Status Verified Date:
2008-12
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase II trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine the time to progression in patients with glioblastoma multiforme or anaplastic astrocytoma primary presentation treated with surgical resection radiotherapy and T cell immunotherapy as initial therapy II Determine the toxic effects of this therapy in these patients
OUTLINE Patients are vaccinated with irradiated autologous tumor cells plus sargramostim GM-CSF intradermally near draining lymph nodes in the groin or axillary regions This is then followed by 3 consecutive days of intradermal injections of GM-CSF only directly into the vaccine sites Enlarged lymph nodes are then removed 7-10 days later and activated with staphylococcal enterotoxin A SEA and interleukin-2 IL-2 T cells are expanded ex vivo over approximately 10 days 1-2 days prior to infusion oral cyclophosphamide is administered as a one time dose The lymphocyte infusion is then administered intravenously Based on availability patients may receive vaccine boosts with additional injections of irradiated autologous tumor cells thawed from the original cryopreserved collection Patients are followed at 1 month and then every 2 months thereafter
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study within 2 years
OUTLINE Patients are vaccinated with irradiated autologous tumor cells plus sargramostim GM-CSF intradermally near draining lymph nodes in the groin or axillary regions This is then followed by 3 consecutive days of intradermal injections of GM-CSF only directly into the vaccine sites Enlarged lymph nodes are then removed 7-10 days later and activated with staphylococcal enterotoxin A SEA and interleukin-2 IL-2 T cells are expanded ex vivo over approximately 10 days 1-2 days prior to infusion oral cyclophosphamide is administered as a one time dose The lymphocyte infusion is then administered intravenously Based on availability patients may receive vaccine boosts with additional injections of irradiated autologous tumor cells thawed from the original cryopreserved collection Patients are followed at 1 month and then every 2 months thereafter
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NCI-H98-0008 | None | None | None |
| CCF-BB-IND-6154 | None | None | None |