Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222443
Status:
COMPLETED
Last Update Posted:
2008-09-22
First Post:
2005-09-20
Brief Title:
Pilot Study Combining Temozolomide Oncovin Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Pilot Study Combining Temozolomide Oncovin Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
Status:
COMPLETED
Status Verified Date:
2008-09
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:
Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan with weekly vincristine temozolomide and vantin to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas
Detailed Description:
Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan with weekly vincristine temozolomide and vantin to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas
Temozolomide is given by mouth one hour prior to each daily irinotecan dose days 1-5 of each cycle 100 mgm2day Irinotecan is given IV in dose escalation minimum of 3 and up to 6 patients per cohort starting at 15 mgm2day daily for 5 days for 2 weeks Vincristin is given IV 15 mgm2dose max dose 2mg days 1 and 8 of each cycle Vantin is given 10 mgkgday divided in 2 oral doses max dose 400 mgday started 48 hours prior to the start of each treatment cycle and continued for 48 hours after last irinotecan dose Cycle repeated every 28 days
Therapy will continue for a minimum of two cycles unless there is progression of disease or unacceptable toxicity and may be continued as long as patient tolerates therapy and there is continued disease control up to one year of therapy
Temozolomide is given by mouth one hour prior to each daily irinotecan dose days 1-5 of each cycle 100 mgm2day Irinotecan is given IV in dose escalation minimum of 3 and up to 6 patients per cohort starting at 15 mgm2day daily for 5 days for 2 weeks Vincristin is given IV 15 mgm2dose max dose 2mg days 1 and 8 of each cycle Vantin is given 10 mgkgday divided in 2 oral doses max dose 400 mgday started 48 hours prior to the start of each treatment cycle and continued for 48 hours after last irinotecan dose Cycle repeated every 28 days
Therapy will continue for a minimum of two cycles unless there is progression of disease or unacceptable toxicity and may be continued as long as patient tolerates therapy and there is continued disease control up to one year of therapy
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