Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005796
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Plus Gene Therapy in Treating Patients With CNS Tumors
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
A Pilot Study of Dose-Intensified Procarbazine CCNU Vincristine PCV for Poor Prognosis Pediatric and Adult Brain Tumors Utilizing Fibronectin-Assisted Retroviral-Mediated Modification of CD34 Peripheral Blood Cells With O6-Methylguanine DNA Methyltransferase
Status:
COMPLETED
Status Verified Date:
2015-03
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Inserting a specific gene into a persons peripheral stem cells may improve the bodys ability to fight cancer or make the cancer more sensitive to chemotherapy
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus gene therapy in treating patients who have CNS tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus gene therapy in treating patients who have CNS tumors
Detailed Description:
OBJECTIVES I Determine the toxicity detection of replication competent retrovirus associated with CD34 cells transduced with a retroviral vector expressing human O6-methylguanine DNA methyltransferase in adult and pediatric patients with poor prognosis CNS tumors II Determine the safety of genetic modification of cells carried out in the presence ex vivo of recombinant fibronectin FN fragment utilized to assist in retroviral entry into mammalian cells III Determine any evidence of engraftment of cells exposed to FN during retroviral transduction IV Determine any evidence of antibodies to FN following infusion of cells exposed to FN during ex vivo retroviral transduction
OUTLINE Patients with surgically approachable lesions undergo maximal surgical debulking that allows preservation of good neurologic functioning Harvest Patients receive filgrastim G-CSF subcutaneously or IV beginning 4 days prior to initiation of first leukapheresis and continuing until completion of harvest Peripheral blood stem cells are harvested and selected for CD34 cells which are transduced with a fibronectin assisted retroviral vector expressing human O6-methylguanine DNA methyltransferase Intensification Patients receive oral lomustine and vincristine IV on day 0 and oral procarbazine on days 1-7 Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with newly diagnosed tumors may undergo involved field radiotherapy IF-RT after completion of the third course of chemotherapy and may begin the fourth course of chemotherapy after completion of IF-RT Transplantation Two-thirds of the transduced CD34 cells are reinfused on day 9 of the first course of chemotherapy The remaining portion one-third of the transduced CD34 cells are reinfused on day 9 of the second course of chemotherapy Untransduced CD34 cells are reinfused on day 9 of the last 3 courses of chemotherapy Patients are followed every 3 months for 6 months every 4 months for 1 year every 6 months through year 5 and then annually thereafter
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 1 year
OUTLINE Patients with surgically approachable lesions undergo maximal surgical debulking that allows preservation of good neurologic functioning Harvest Patients receive filgrastim G-CSF subcutaneously or IV beginning 4 days prior to initiation of first leukapheresis and continuing until completion of harvest Peripheral blood stem cells are harvested and selected for CD34 cells which are transduced with a fibronectin assisted retroviral vector expressing human O6-methylguanine DNA methyltransferase Intensification Patients receive oral lomustine and vincristine IV on day 0 and oral procarbazine on days 1-7 Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with newly diagnosed tumors may undergo involved field radiotherapy IF-RT after completion of the third course of chemotherapy and may begin the fourth course of chemotherapy after completion of IF-RT Transplantation Two-thirds of the transduced CD34 cells are reinfused on day 9 of the first course of chemotherapy The remaining portion one-third of the transduced CD34 cells are reinfused on day 9 of the second course of chemotherapy Untransduced CD34 cells are reinfused on day 9 of the last 3 courses of chemotherapy Patients are followed every 3 months for 6 months every 4 months for 1 year every 6 months through year 5 and then annually thereafter
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-H00-0049 | None | None | None |
| IUMC-9607-22 | None | None | None |