Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

Completed · Phase 1

Conditions studied: Lymphomas, Tumors

In brief

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.

Key facts

Study ID

NCT00222443

Run by

University of Oklahoma

People needed

40

Starts

2004-09-01

Expected to finish

2007-12-01

Last updated by the study team

2008-09-22

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oklahoma University Health Sciences Center-Jimmy Everest Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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