Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphomas Tumors |
Drug: Irinotecan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | 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.
- Evaluate feasibility of repetitive cycles of this combination .
- Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Under age 21 years at time of study entry
- Malignant solid tumor, including CNS tumors and lymphomas
- Recurrent or refractory disease not amenable to other potentially curative therapies
- At least three weeks since last myelosuppressive chemotherapy > 6 months from allogeneic stem cell transplant
- Adequate renal and hepatic function
- Adequate peripheral blood counts unless bone marrow is involved
Exclusion Criteria:
- Patients with leukemia not eligible
- Patients with uncontrolled infection excluded
- Patients who have received more than 4 prior chemotherapies
- Patients who are receiving P450 enzyme-inducing anticonvulsants
- Patients who are receiving any other cancer chemotherapy or any other investigational agent
- Possible pregnancy will be excluded
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00222443 History of Changes |
| Obsolete Identifiers: | NCT00277719 |
| Other Study ID Numbers: | JEC Toca One |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 19, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
Recurrent solid tumors recurrent lymphomas Pediatrics Adolescents |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Anti-Bacterial Agents Temozolomide Irinotecan Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013