Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003067
Status:
SUSPENDED
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Patients With Primary or Advanced Glioma
Sponsor:
Weill Medical College of Cornell University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intracavitary Interleukin-2 IL-2 and Lymphokine-Activated Killer LAK Cell Therapy for Malignant Gliomas
Status:
SUSPENDED
Status Verified Date:
2008-10
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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells in patients with primary or advanced glioma
PURPOSE Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary recurrent or refractory malignant glioma
PURPOSE Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary recurrent or refractory malignant glioma
Detailed Description:
OBJECTIVES
Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary recurrent or refractory malignant gliomas
Determine whether the induction of a regional intracavitary eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients
OUTLINE Patients receive cytoreductive tumor surgery andor biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction
Patients undergo outpatient leukapheresis on day -4 or -5 and cells are incubated ex vivo with interleukin-2 IL-2 Lymphokine-activated killer LAK cells and IL-2 are infused on day 1 Bolus infusions of low-dose IL-2 are administered on days 3 5 8 10 and 12 followed by a rest period on days 13-24 The course is repeated on day 25 starting with leukapheresis Therapy courses are repeated for up to 1 year for stable disease or response to therapy Maintenance doses repeat every 4-6 months thereafter
Disease restaging is done every 8-12 weeks
PROJECTED ACCRUAL A total of 30 patients per year will be enrolled
Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary recurrent or refractory malignant gliomas
Determine whether the induction of a regional intracavitary eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients
OUTLINE Patients receive cytoreductive tumor surgery andor biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction
Patients undergo outpatient leukapheresis on day -4 or -5 and cells are incubated ex vivo with interleukin-2 IL-2 Lymphokine-activated killer LAK cells and IL-2 are infused on day 1 Bolus infusions of low-dose IL-2 are administered on days 3 5 8 10 and 12 followed by a rest period on days 13-24 The course is repeated on day 25 starting with leukapheresis Therapy courses are repeated for up to 1 year for stable disease or response to therapy Maintenance doses repeat every 4-6 months thereafter
Disease restaging is done every 8-12 weeks
PROJECTED ACCRUAL A total of 30 patients per year will be enrolled
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1326 | None | None | None |
| NYWCCC-0902499 | None | None | None |
| NYWCCC-IMMUNE-0902499 | None | None | None |
| SIUH-RP-96-004 | None | None | None |