Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048386
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2002-10-30
Brief Title:
Neuroblastoma Vaccine for Treatment of High-Risk Neuroblastoma After Chemotherapy
Sponsor:
Malcolm Brenner
Organization:
Baylor College of Medicine
Study Overview
Official Title:
A Pilot Study of Gene Modified Autologous Neuroblastoma Vaccine for the Post-Chemotherapy Treatment of High-Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2012-07
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:
CYCHE2
Brief Summary:
PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in first or subsequent partial response or better or with microscopic residual bone marrow disease who demonstrate an immunological anti-tumor response at any time during and for up to 12 months from initiation of treatment with subcutaneous injections of autologous neuroblastoma cells genetically modified by adenoviral vectors to secrete interleukin-2 IL-2 autologous neuroblastoma vaccine
SECONDARY OBJECTIVES 1 To determine the toxicity of the autologous neuroblastoma vaccine given according to this schedule 2 To obtain preliminary data on the effect of vaccine administration on progression-free survival from high-risk neuroblastoma
SECONDARY OBJECTIVES 1 To determine the toxicity of the autologous neuroblastoma vaccine given according to this schedule 2 To obtain preliminary data on the effect of vaccine administration on progression-free survival from high-risk neuroblastoma
Detailed Description:
Tumor cells from subjects with high-risk neuroblastoma will be obtained at the time of presentation and initial diagnosis during routine surveillance of bone marrow disease status or at the time of surgical resection of disease during primary chemotherapy The tumor cells will be irradiated to prevent the possibility of tumor growth Autologous neuroblastoma tumor cells will be used to treat neuroblastoma following the completion of primary or salvage chemotherapy when peripheral blood lymphocyte counts have recovered to 500 CD3 cellsmm3 This preceding chemotherapy may or may not have included bone marrow or peripheral stem cell rescue Therefore following the achievement of best response with chemotherapy vaccine will be administered for 6 months Vaccine modified for secretion of IL-2 will be used
Vaccine therapy will commence after complete recovery from the side effects of primary or salvage chemotherapy as long as the subject has an absolute CD3 lymphocyte count and an absolute neutrophil count greater than 500mm3 A vaccine consisting of 03 x 10 8 cellspatient will be given per injection based on data from the Phase I studies Injections will be given twice monthly for two months then monthly for four months for a total of eight vaccine injections over six months The immune effects of the vaccine toxicity of treatment and anti-tumor effects will be periodically assessed Further evaluation will be done annually
The first and second vaccine injection sites will be punch biopsied one week after the injection Several x-rays and various types of scans will also be taken to assist with monitoring the status of the neuroblastoma Complete details of the evaluations required by this study are included in
Subjects may receive supportive care for any acute or chronic toxicity from the injections including blood product support antibiotics and other appropriate intervention Pneumocystis carinii prophylaxis initiated during chemotherapy may be continued during vaccine therapy for as long as deemed appropriate by the investigator As well subjects may receive concurrent therapy with cis-retinoic acid at the discretion of the treating physician
An adenoviral vector is being used to transduce the cells ex-vivo Subjects will not be treated with the viral vector
Vaccine therapy will commence after complete recovery from the side effects of primary or salvage chemotherapy as long as the subject has an absolute CD3 lymphocyte count and an absolute neutrophil count greater than 500mm3 A vaccine consisting of 03 x 10 8 cellspatient will be given per injection based on data from the Phase I studies Injections will be given twice monthly for two months then monthly for four months for a total of eight vaccine injections over six months The immune effects of the vaccine toxicity of treatment and anti-tumor effects will be periodically assessed Further evaluation will be done annually
The first and second vaccine injection sites will be punch biopsied one week after the injection Several x-rays and various types of scans will also be taken to assist with monitoring the status of the neuroblastoma Complete details of the evaluations required by this study are included in
Subjects may receive supportive care for any acute or chronic toxicity from the injections including blood product support antibiotics and other appropriate intervention Pneumocystis carinii prophylaxis initiated during chemotherapy may be continued during vaccine therapy for as long as deemed appropriate by the investigator As well subjects may receive concurrent therapy with cis-retinoic acid at the discretion of the treating physician
An adenoviral vector is being used to transduce the cells ex-vivo Subjects will not be treated with the viral vector
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 |
|---|---|---|---|
| HIGH RISK NEUROBLASTOMA | None | None | None |