Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003811
Status:
COMPLETED
Last Update Posted:
2013-07-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
High-Dose Cisplatin Etoposide and Bleomycin HD-PEB Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-07
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:
None
Brief Summary:
RATIONALE Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase I trial to study the effectiveness of high-dose cisplatin etoposide and bleomycin plus amifostine in treating children who have malignant germ cell tumors
PURPOSE Phase I trial to study the effectiveness of high-dose cisplatin etoposide and bleomycin plus amifostine in treating children who have malignant germ cell tumors
Detailed Description:
OBJECTIVES I Evaluate the early efficacy and toxicity profile of high-dose cisplatin etoposide bleomycin and amifostine in children with newly diagnosed high-risk malignant extragonadal germ cell tumors II Determine whether the use of amifostine can reduce the hematologic and nonhematologic toxic effects of this combination chemotherapy in these patients when compared to similar patients treated on POG-9049CCG-8881 with the same combination chemotherapy III Determine the response rate of patients treated with this regimen
OUTLINE Patients undergo surgical biopsy or resection Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour amifostine IV over 15 minutes and cisplatin IV over 1 hour on days 1-5 Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression Patients who have no disease after 4 courses of chemotherapy receive no further treatment Patients who have residual disease undergo second-look surgery After surgery patients who still have active tumor receive 2 additional courses of chemotherapy Those patients who still have tumor after the 2 additional courses may have a third surgery Patients are followed every month for 6 months every 2 months for 6 months every 6 months for 1 year and then annually thereafter until death
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 139 years
OUTLINE Patients undergo surgical biopsy or resection Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour amifostine IV over 15 minutes and cisplatin IV over 1 hour on days 1-5 Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression Patients who have no disease after 4 courses of chemotherapy receive no further treatment Patients who have residual disease undergo second-look surgery After surgery patients who still have active tumor receive 2 additional courses of chemotherapy Those patients who still have tumor after the 2 additional courses may have a third surgery Patients are followed every month for 6 months every 2 months for 6 months every 6 months for 1 year and then annually thereafter until death
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 139 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 |
|---|---|---|---|
| CDR0000066956 | OTHER | Clinical Trialsgov | None |
| POG-9749 | OTHER | None | None |