Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001564
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
1999-11-03
Brief Title:
A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
Status:
COMPLETED
Status Verified Date:
2014-09-04
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:
Arm A
Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched for professional APCs
T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte rich fraction is collected
Autologous T cell transplantation during immunotherapy
Arm B
Cell harvesting is performed as soon as possible
Both Arm A and B
Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell vaccination APC products as well as intramuscular injection of influenza vaccine on the same day
Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by continuous intravenous infusion for 4 days per week for 3 successive weeks
Primary toxic effect of this therapy is expected to be related to the IL-2 therapy Patients with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2 therapy If toxic effect is not resolved in 72-hours the patient may remain on study but will not receive any further IL-2
Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched for professional APCs
T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte rich fraction is collected
Autologous T cell transplantation during immunotherapy
Arm B
Cell harvesting is performed as soon as possible
Both Arm A and B
Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell vaccination APC products as well as intramuscular injection of influenza vaccine on the same day
Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by continuous intravenous infusion for 4 days per week for 3 successive weeks
Primary toxic effect of this therapy is expected to be related to the IL-2 therapy Patients with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2 therapy If toxic effect is not resolved in 72-hours the patient may remain on study but will not receive any further IL-2
Detailed Description:
Nearly all patients with non-metastatic Ewings sarcoma family of tumors ESFT and alveolar rhabdomyosarcoma AR have a dramatic initial response to multiagent chemotherapy However approximately 30 percent of patients develop recurrent disease for which conventional chemotherapy is ineffective and treatment options are limited Immunotherapy may represent an effective approach for treatment of recurrent ESFT and AR Experimental evidence has shown that immune mediated anti-tumor effects can occur in vivo when T cells recognize and respond to antigens present on tumor cells In ESFT and AR tumor-specific chromosomal translocations resulting in the production of novel fusion proteins have been identified in the great majority of tumors Peptides derived from these fusion proteins have been shown to function as tumor antigens for cytolytic T cells in animal studies This protocol will study the safety feasibility and efficacy of tumor-specific peptide vaccination administered with interleukin-2 therapy with or without autologous T cell infusions in patients with recurrent ESFT and AR
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 |
|---|---|---|---|
| 97-C-0050 | None | None | None |