A Phase 1 interventional study of Irinotecan in Lymphomas and Tumors, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2008-09-22.
Sponsored by University of Oklahoma · Phase 1, Interventional, and Diagnostic
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.
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 mg/m2/day. Irinotecan is given IV in dose escalation (minimum of 3 and up to 6 patients per cohort) starting at 15 mg/m2/day daily for 5 days for 2 weeks. Vincristin is given IV 1.5 mg/m2/dose (max dose 2mg) days 1 and 8 of each cycle. Vantin is given 10 mg/kg/day divided in 2 oral doses (max dose 400 mg/day) 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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
Evaluate feasibility of repetitive cycles of this combination .
Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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University of Oklahoma