Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006480
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2000-11-06
Brief Title:
Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase I Study to Evaluate the Safety of Cellular Immunotherapy for RecurrentRefractory Neuroblastoma Using Genetically-Modified Autologous CD8 T Cell Clones
Status:
COMPLETED
Status Verified Date:
2010-09
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 therapies use different ways to stimulate the immune system and stop cancer cell from growing Inserting genetic material made in the laboratory into a persons blood cells may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of biological therapy and gene therapy in treating children who have recurrent or refractory neuroblastoma
PURPOSE Phase I trial to study the effectiveness of biological therapy and gene therapy in treating children who have recurrent or refractory neuroblastoma
Detailed Description:
OBJECTIVES I Determine the safety and toxicity of cellular immunotherapy using ex vivo expanded autologous CD8 cytotoxic T-lymphocyte clones genetically modified to express the CE7R scFvFczeta chimeric immunoreceptor and the HyTK selectionsuicide gene in children with recurrent or refractory disseminated neuroblastoma II Determine the antitumor activity of this regimen in these patients III Determine the duration of in vivo persistence of adoptively transferred clones and the effect of interleukin-2 on maintaining the in vivo persistence of these clones IV Screen for the development of host anti-scFvFczeta and HyTK immune responses in patients treated with this regimen V Determine the efficacy of ganciclovir in ablating transferred clones in vivo if toxicity occurs in these patients
OUTLINE This is a multicenter study Patients undergo autologous peripheral blood stem cell harvest CD8 cytotoxic T-lymphocyte CTL clones are isolated genetically modified to express the CE7R scFvFczeta chimeric immunoreceptor and the HyTK selectionsuicide gene and then expanded ex vivo While the modified CTL clones are being generated patients each receive an individualized salvage chemotherapy regimen that may consist of one of the following cyclophosphamide and topotecan ifosfamide carboplatin and etoposide or another chemotherapy regimen chosen by the patients primary oncologist The first cohort of 5 patients receives escalating doses of modified CTL clones IV over 30 minutes on days 0 14 and 28 in the absence of disease progression or unacceptable toxicity Each patient begins the series of 3 infusions as soon as an adequate number of modified CTL clones are ready and after the acute side effects of chemotherapy have resolved In the absence of unacceptable toxicity in the first cohort the second cohort of 5 patients receives the same treatment as cohort 1 plus interleukin-2 subcutaneously every 12 hours on days 15-24 and 29-38 Patients with unacceptable toxicity receive ganciclovir IV every 12 hours for 14 days or longer if symptomatic resolution is not achieved in that interval Patients are followed at day 100 and then periodically thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 3 years
OUTLINE This is a multicenter study Patients undergo autologous peripheral blood stem cell harvest CD8 cytotoxic T-lymphocyte CTL clones are isolated genetically modified to express the CE7R scFvFczeta chimeric immunoreceptor and the HyTK selectionsuicide gene and then expanded ex vivo While the modified CTL clones are being generated patients each receive an individualized salvage chemotherapy regimen that may consist of one of the following cyclophosphamide and topotecan ifosfamide carboplatin and etoposide or another chemotherapy regimen chosen by the patients primary oncologist The first cohort of 5 patients receives escalating doses of modified CTL clones IV over 30 minutes on days 0 14 and 28 in the absence of disease progression or unacceptable toxicity Each patient begins the series of 3 infusions as soon as an adequate number of modified CTL clones are ready and after the acute side effects of chemotherapy have resolved In the absence of unacceptable toxicity in the first cohort the second cohort of 5 patients receives the same treatment as cohort 1 plus interleukin-2 subcutaneously every 12 hours on days 15-24 and 29-38 Patients with unacceptable toxicity receive ganciclovir IV every 12 hours for 14 days or longer if symptomatic resolution is not achieved in that interval Patients are followed at day 100 and then periodically thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| CDR0000068310 | REGISTRY | PDQ | None |
| FHCRC-152400 | None | None | None |
| NCI-H00-0065 | None | None | None |