Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019357
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Cellular Immunotherapy With Autologous T Lymphocytes Stimulated With the Patients Tumor-Specific Mutated Ras Peptides
Status:
COMPLETED
Status Verified Date:
2001-08
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 Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Combining white blood cells which have been activated by a vaccine with interleukin-2 may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-2 plus activated white blood cells in treating patients with cancer that has not responded to chemotherapy or radiation therapy
PURPOSE Phase I trial to study the effectiveness of interleukin-2 plus activated white blood cells in treating patients with cancer that has not responded to chemotherapy or radiation therapy
Detailed Description:
OBJECTIVES I Determine the feasibility of expansion and the reinfusion of specific T-cell lines peptide-specific activated lymphocytes in combination with interleukin-2 in patients who were vaccinated with ras peptides II Assess immunologic status or antitumor response that may occur with this treatment in these patients
OUTLINE Autologous peptide-specific activated lymphocytes PAL previously harvested from the patient following vaccination on a different protocol are expanded and reinfused intravenously this is followed by a 4 hour observation period Patients then receive interleukin-2 IL-2 administered subcutaneously 5 days a week for 2 weeks the first dose of IL-2 is administered at least 4 hours after PAL infusion Patients are followed once a month for 2 months after treatment
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
OUTLINE Autologous peptide-specific activated lymphocytes PAL previously harvested from the patient following vaccination on a different protocol are expanded and reinfused intravenously this is followed by a 4 hour observation period Patients then receive interleukin-2 IL-2 administered subcutaneously 5 days a week for 2 weeks the first dose of IL-2 is administered at least 4 hours after PAL infusion Patients are followed once a month for 2 months after treatment
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
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-97-C-0144 | None | None | None |
| NCI-T97-0059 | None | None | None |