Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004919
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2000-03-07
Brief Title:
Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of Irinotecan and Cisplatin in Children With Refractory Solid Tumors
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:
Drugs used in chemotherapy 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 Phase I trial to study the effectiveness of irinotecan and cisplatin with or without amifostine in treating children who have solid tumors that have not responded to previous therapy
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of irinotecan when administered with cisplatin with or without amifostine to children with refractory solid tumors
II Determine the dose limiting toxicities of the combination of irinotecan and cisplatin with and without amifostine in this patient population
III Determine the pharmacokinetics of cisplatin with and without amifostine in these patients
IV Quantify the leukocyte DNA-platinum adduct formation with and without amifostine and correlate it with response and toxicity in these patients
V Determine the safety and efficacy of the doses and schedules of administration to be used in phase II clinical trials
OUTLINE This is a dose escalation study of irinotecan
Treatment A Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1 8 15 and 22 Courses repeat every 6 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression
Treatment B Patients receive therapy as in treatment A In addition amifostine IV is administered over 15 minutes immediately before cisplatin
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Once the MTD of treatment A is determined additional patients are accrued to determine the MTD of treatment B
If myelosuppression is the dose limiting toxicity of treatment A then stratum 1 closes and stratum 2 opens and these patients with less prior therapy receive treatment A Treatment B is then only open to stratum 3 patients
Patients are followed every 6 months for 4 years then annually thereafter
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 25 years
I Determine the maximum tolerated dose MTD of irinotecan when administered with cisplatin with or without amifostine to children with refractory solid tumors
II Determine the dose limiting toxicities of the combination of irinotecan and cisplatin with and without amifostine in this patient population
III Determine the pharmacokinetics of cisplatin with and without amifostine in these patients
IV Quantify the leukocyte DNA-platinum adduct formation with and without amifostine and correlate it with response and toxicity in these patients
V Determine the safety and efficacy of the doses and schedules of administration to be used in phase II clinical trials
OUTLINE This is a dose escalation study of irinotecan
Treatment A Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1 8 15 and 22 Courses repeat every 6 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression
Treatment B Patients receive therapy as in treatment A In addition amifostine IV is administered over 15 minutes immediately before cisplatin
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Once the MTD of treatment A is determined additional patients are accrued to determine the MTD of treatment B
If myelosuppression is the dose limiting toxicity of treatment A then stratum 1 closes and stratum 2 opens and these patients with less prior therapy receive treatment A Treatment B is then only open to stratum 3 patients
Patients are followed every 6 months for 4 years then annually thereafter
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |
| P9970 | None | None | None |
| CDR0000067601 | None | None | None |
| CCG-P9970 | None | None | None |