Clinical trial · Interventional
Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
NCT00222443CI-TRIAL-00001689completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
- measure
- Evaluate feasibility of repetitive cycles of this combination .
Secondary outcomes (1)
- measure
- Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.