Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047320
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2002-10-03
Brief Title:
Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy PlusMinus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT
Status:
COMPLETED
Status Verified Date:
2018-01
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 work in different ways to stop tumor cells from dividing so they stop growing or die Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Combining different types of therapy may kill more tumor cells
PURPOSE This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors
PURPOSE This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors
Detailed Description:
OBJECTIVES
Determine the response rate of patients with non-germinomatous germ cell tumors treated with neoadjuvant chemotherapy
Determine the progression-free survival and overall survival of patients treated with neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy with or without autologous peripheral blood stem cell transplantation PBSCT
Determine whether additional complete responses can be achieved after high-dose thiotepa and etoposide with PBSCT in patients with persistently positive markers histological evidence of residual malignant elements or unresectable residual tumors after initial neoadjuvant chemotherapy
Determine patterns of recurrence in patients treated with this regimen
Correlate tumor marker response with radiographic and clinical measures of response as well as findings at second-look surgery in patients with radiological evidence of residual disease
OUTLINE
Induction chemotherapy
Courses 1 3 and 5 Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 Beginning on day 4 patients receive filgrastim G-CSF IV or subcutaneously SC for 10 days or until blood counts recover Courses are 3 weeks in duration
Courses 2 4 and 6 Patients receive etoposide IV over 1 hour followed by ifosfamide IV over 1 hour on days 1-5 Beginning on day 6 patients receive G-CSF IV or SC for 10 days or until blood counts recover Courses are 3 weeks in duration
Patients undergo re-evaluation Patients with a complete response CR go directly to radiotherapy Approximately 3 weeks after completion of induction chemotherapy all patients with less than a CR are encouraged to undergo second-look surgery
After second-look surgery patients with a CR or a partial response PR go directly to radiotherapy Patients with less than a PR undergo consolidation chemotherapy with peripheral blood stem cell rescue PBSC followed by radiotherapy
Consolidation chemotherapy Patients undergo PBSC collection Patients receive G-CSF SC until PBSC collection is complete Patients then receive thiotepa IV over 3 hours followed by etoposide IV over 3 hours on days -5 to -3 PBSCs are reinfused on day 0 Beginning on day 1 and continuing until blood counts recover patients receive G-CSF SC daily
Radiotherapy All patients receive radiotherapy once daily 5 days a week for 5-6 weeks beginning after recovery from induction chemotherapy or second-look surgery or within 9 weeks after PBSC reinfusion
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 80-100 patients will be accrued for this study within 36-42 months
Determine the response rate of patients with non-germinomatous germ cell tumors treated with neoadjuvant chemotherapy
Determine the progression-free survival and overall survival of patients treated with neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy with or without autologous peripheral blood stem cell transplantation PBSCT
Determine whether additional complete responses can be achieved after high-dose thiotepa and etoposide with PBSCT in patients with persistently positive markers histological evidence of residual malignant elements or unresectable residual tumors after initial neoadjuvant chemotherapy
Determine patterns of recurrence in patients treated with this regimen
Correlate tumor marker response with radiographic and clinical measures of response as well as findings at second-look surgery in patients with radiological evidence of residual disease
OUTLINE
Induction chemotherapy
Courses 1 3 and 5 Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 Beginning on day 4 patients receive filgrastim G-CSF IV or subcutaneously SC for 10 days or until blood counts recover Courses are 3 weeks in duration
Courses 2 4 and 6 Patients receive etoposide IV over 1 hour followed by ifosfamide IV over 1 hour on days 1-5 Beginning on day 6 patients receive G-CSF IV or SC for 10 days or until blood counts recover Courses are 3 weeks in duration
Patients undergo re-evaluation Patients with a complete response CR go directly to radiotherapy Approximately 3 weeks after completion of induction chemotherapy all patients with less than a CR are encouraged to undergo second-look surgery
After second-look surgery patients with a CR or a partial response PR go directly to radiotherapy Patients with less than a PR undergo consolidation chemotherapy with peripheral blood stem cell rescue PBSC followed by radiotherapy
Consolidation chemotherapy Patients undergo PBSC collection Patients receive G-CSF SC until PBSC collection is complete Patients then receive thiotepa IV over 3 hours followed by etoposide IV over 3 hours on days -5 to -3 PBSCs are reinfused on day 0 Beginning on day 1 and continuing until blood counts recover patients receive G-CSF SC daily
Radiotherapy All patients receive radiotherapy once daily 5 days a week for 5-6 weeks beginning after recovery from induction chemotherapy or second-look surgery or within 9 weeks after PBSC reinfusion
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 80-100 patients will be accrued for this study within 36-42 months
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 |
|---|---|---|---|
| COG-ACNS0122 | OTHER | Childrens Oncology Group | None |
| CDR0000257664 | OTHER | None | None |