Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001566
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
1999-11-03
Brief Title:
A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
Status:
COMPLETED
Status Verified Date:
2012-06
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:
This is a single arm study
The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell APC vaccine is performed
Fresh APCs are utilized for initial priming vaccination All subsequent vaccinations will use cryopreserved APCs Minimum number of APCs administered per vaccination is 100000kg and maximum is 100000000kg
Patients undergo cytoreductive therapy for the treatment of their particular malignancy This therapy usually consists of multiagent chemotherapy in the context of a separate protocol
Following chemotherapy infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations Influenza vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines
Interleukin -2 IL-2 is administered as a continuous intravenous IV infusion for 4 daysweek for 3 successive weeks starting on the same day as T cell peptide-pulsed infusions
The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell APC vaccine is performed
Fresh APCs are utilized for initial priming vaccination All subsequent vaccinations will use cryopreserved APCs Minimum number of APCs administered per vaccination is 100000kg and maximum is 100000000kg
Patients undergo cytoreductive therapy for the treatment of their particular malignancy This therapy usually consists of multiagent chemotherapy in the context of a separate protocol
Following chemotherapy infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations Influenza vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines
Interleukin -2 IL-2 is administered as a continuous intravenous IV infusion for 4 daysweek for 3 successive weeks starting on the same day as T cell peptide-pulsed infusions
Detailed Description:
Eradication of low tumor burdens can occur in vivo when T-cell mediated responses are generated against specific tumor antigens The Ewings sarcoma family of tumors ESFT and alveolar rhabdomyosarcoma AR display several features which make them candidate diseases for trials of such immunotherapy First intensive cytotoxic chemotherapy is generally able to eradicate bulk disease in patients with metastatic disease but tumor relapse eventually occurs in nearly all patients Second tumor-specific chromosomal translocations resulting in the production of novel fusion proteins have been identified in the great majority of these tumors Peptides derived from these fusion proteins have been shown to function as tumor antigens for cytolytic T cells in animal studies Third studies of immune reconstitution after intensive cytotoxic therapy have provided evidence that antigen-specific T cells can be generated in vivo when the adoptive transfer of peripheral T cells and antigen are provided during the period of T cell regeneration This process can be augmented in murine models by the use of human immunodeficiency virus HIV active protease inhibitor indinavir potentially through inhibition of programmed cell death in expanding T cells Merging these concepts this protocol will attempt to eradicate minimal residual disease in pediatric patients with metastatic ESFT and AR via vaccination with tumor-specific peptides undertaken concomitant with autologous T cell transplantation and indinavir
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-0052 | None | None | None |