Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101309
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2005-01-07
Brief Title:
Vaccine Therapy and Interleukin-2 in Treating Young Patients With Relapsed or Refractory Ewings Sarcoma or Neuroblastoma
Sponsor:
Milton S Hershey Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pilot Study of Tumor Cell - B Lymphoblastoid Cell Line Vaccination in Pediatric Subjects With Relapsed Ewings Sarcoma and Neuroblastoma
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Vaccines made from a persons tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells Interleukin-2 IL-2 may stimulate the white blood cells to kill tumor cells Biological therapies such as cellular adoptive immunotherapy stimulate the immune system and stop tumor cells from growing Giving vaccine therapy with IL-2 may be a more effective treatment for Ewings sarcoma or neuroblastoma
PURPOSE This phase I trial is studying the side effects of vaccine therapy when given with IL-2 in treating young patients with relapsed or refractory Ewings sarcoma or neuroblastoma
PURPOSE This phase I trial is studying the side effects of vaccine therapy when given with IL-2 in treating young patients with relapsed or refractory Ewings sarcoma or neuroblastoma
Detailed Description:
OBJECTIVES
Determine the safety of vaccination comprising autologous tumor cells fused with Epstein-Barr virus-transformed B-lymphoblastoid cells followed by interleukin-2 IL-2 in children with relapsed or refractory Ewings sarcoma or neuroblastoma
Determine antitumor immunity by examining cell phenotype and function in patients treated with this vaccine and cytotoxic T lymphocytes CTL
Determine the safety of CTL and IL-2 in these patients
OUTLINE This is a pilot study
Tumor cells and blood cells are collected from patients and expanded in vitro Tumor cells and Epstein-Barr virus-transformed B-lymphoblastoid cells derived from blood cells are fused together to produce the vaccine
Vaccination Patients receive vaccine comprising autologous tumor cells fused with Epstein-Barr virus-transformed B-lymphoblastoid cells subcutaneously SC once on days 0 14 and 28 and interleukin-2 IL-2 SC twice daily on days 1-7 15-21 and 29-35
Cytotoxic T lymphocytes CTL After vaccination patients with evidence of antitumor immunity undergo leukapheresis to collect white blood cells for CTL expansion Some of these patients then receive CTL IV once on days 0 14 and 28 and IL-2 SC twice daily on days 1-7 15-21 and 29-35
Patients are followed weekly for 2 weeks every 2 weeks for 1 month monthly for 3 months and then every 2 months for up to 1 year post-vaccination Patients who receive CTL are also followed annually for survival
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 3 years
Determine the safety of vaccination comprising autologous tumor cells fused with Epstein-Barr virus-transformed B-lymphoblastoid cells followed by interleukin-2 IL-2 in children with relapsed or refractory Ewings sarcoma or neuroblastoma
Determine antitumor immunity by examining cell phenotype and function in patients treated with this vaccine and cytotoxic T lymphocytes CTL
Determine the safety of CTL and IL-2 in these patients
OUTLINE This is a pilot study
Tumor cells and blood cells are collected from patients and expanded in vitro Tumor cells and Epstein-Barr virus-transformed B-lymphoblastoid cells derived from blood cells are fused together to produce the vaccine
Vaccination Patients receive vaccine comprising autologous tumor cells fused with Epstein-Barr virus-transformed B-lymphoblastoid cells subcutaneously SC once on days 0 14 and 28 and interleukin-2 IL-2 SC twice daily on days 1-7 15-21 and 29-35
Cytotoxic T lymphocytes CTL After vaccination patients with evidence of antitumor immunity undergo leukapheresis to collect white blood cells for CTL expansion Some of these patients then receive CTL IV once on days 0 14 and 28 and IL-2 SC twice daily on days 1-7 15-21 and 29-35
Patients are followed weekly for 2 weeks every 2 weeks for 1 month monthly for 3 months and then every 2 months for up to 1 year post-vaccination Patients who receive CTL are also followed annually for survival
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| PSCI-18990 | None | None | None |