Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
William H Meyer, MD
University of Oklahoma
United States: Institutional Review Board
JEC Toca One
|Oklahoma University Health Sciences Center-Jimmy Everest Center||Oklahoma City, Oklahoma 73104|