Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002572
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Brief Title:
Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors
Status:
COMPLETED
Status Verified Date:
2000-07
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 therapy uses different ways to stimulate the immune system and stop cancer cells from growing Cytotoxic T cells combined with interleukin-2 may be an effective treatment for recurrent brain tumors
PURPOSE Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in treating adults with recurrent brain tumors
PURPOSE Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in treating adults with recurrent brain tumors
Detailed Description:
OBJECTIVES I Evaluate the toxicity of allogeneic cytotoxic T lymphocytes CTL when repeatedly instilled directly into the brain to treat recurrent primary brain tumors II Evaluate the response produced by allogeneic CTL and interleukin-2 III Correlate CTL surface phenotype and degree of patientdonor HLA mismatch to response and toxicity
OUTLINE Surgery plus Biological Response Modifier Therapy Tumor resection plus intracavitary cytotoxic T lymphocytes CTL intracavitary Interleukin-2 Chiron IL-2 NSC-373364 CTL are generated in vitro by mixing irradiated patient lymphocytes cultured with IL-2 and Monoclonal Antibody OKT 3 MOAB OKT 3 NSC-618843 with allogeneic lymphocytes and culturing the mixture with IL-2
PROJECTED ACCRUAL 10 patients will be treated If severe toxicity occurs in the first 5 patients the study will close
OUTLINE Surgery plus Biological Response Modifier Therapy Tumor resection plus intracavitary cytotoxic T lymphocytes CTL intracavitary Interleukin-2 Chiron IL-2 NSC-373364 CTL are generated in vitro by mixing irradiated patient lymphocytes cultured with IL-2 and Monoclonal Antibody OKT 3 MOAB OKT 3 NSC-618843 with allogeneic lymphocytes and culturing the mixture with IL-2
PROJECTED ACCRUAL 10 patients will be treated If severe toxicity occurs in the first 5 patients the study will close
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-T94-0065O | None | None | None |
| UCHSC-COMIRB-93426 | None | None | None |