Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
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|ClinicalTrials.gov Identifier: NCT00222443|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2008
|Condition or disease||Intervention/treatment||Phase|
|Lymphomas Tumors||Drug: Irinotecan||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222443
|United States, Oklahoma|
|Oklahoma University Health Sciences Center-Jimmy Everest Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||William H Meyer, MD||University of Oklahoma|