Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066482
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2003-08-06
Brief Title:
Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Pilot Study of Cisplatin Etoposide Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2013-10
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
PURPOSE Phase I trial to study the effect on the body of combining cyclophosphamide with cisplatin etoposide and bleomycin in treating children who have newly diagnosed malignant germ cell tumors that are not in the brain and gonads
PURPOSE Phase I trial to study the effect on the body of combining cyclophosphamide with cisplatin etoposide and bleomycin in treating children who have newly diagnosed malignant germ cell tumors that are not in the brain and gonads
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and toxicity profile of cyclophosphamide in combination with bleomycin etoposide and cisplatin in pediatric patients with newly diagnosed high-risk extracranial extragonadal malignant germ cell tumors
Determine the response rate in patients treated with this regimen
OUTLINE This is a pilot multicenter dose-escalation study of cyclophosphamide
Induction therapy Patients receive bleomycin IV over 10-20 minutes on day 1 etoposide IV over 1 hour and cisplatin IV over 4 hours on days 1-5 and cyclophosphamide IV over 1 hour on day 1 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 6 and continuing until blood counts recover Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are evaluated after 4 courses of therapy Patients with partial response or stable disease undergo second-look surgery receive 2 more courses of induction therapy and are then re-evaluated Patients who do not achieve complete response CR after a total of 6 courses may undergo a third surgery Patients who still have tumor that cannot be removed are removed from study therapy Patients who achieve a CR at anytime are followed
Patients are followed monthly for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 6-18 patients will be accrued for this study within 13 years
Determine the maximum tolerated dose and toxicity profile of cyclophosphamide in combination with bleomycin etoposide and cisplatin in pediatric patients with newly diagnosed high-risk extracranial extragonadal malignant germ cell tumors
Determine the response rate in patients treated with this regimen
OUTLINE This is a pilot multicenter dose-escalation study of cyclophosphamide
Induction therapy Patients receive bleomycin IV over 10-20 minutes on day 1 etoposide IV over 1 hour and cisplatin IV over 4 hours on days 1-5 and cyclophosphamide IV over 1 hour on day 1 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 6 and continuing until blood counts recover Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are evaluated after 4 courses of therapy Patients with partial response or stable disease undergo second-look surgery receive 2 more courses of induction therapy and are then re-evaluated Patients who do not achieve complete response CR after a total of 6 courses may undergo a third surgery Patients who still have tumor that cannot be removed are removed from study therapy Patients who achieve a CR at anytime are followed
Patients are followed monthly for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 6-18 patients will be accrued for this study within 13 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 |
|---|---|---|---|
| CDR0000316244 | OTHER | Clinical Trialsgov | None |