Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With … (NCT01518413) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors
United States17 participantsStarted 2011-12
Plain-language summary
The purpose of this study is to determine the safest and most effective oral dose combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e. relapsed or refractory.
Who can participate
Age range2 Years – 22 Years
SexALL
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Inclusion Criteria:
* AGE: \>=2 year and \<22 years of age.
* DIAGNOSIS: solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors and brain tumors.
* MEASURABLE/EVALUABLE DISEASE: Patients must have measurable or evaluable disease.
* THERAPEUTIC OPTIONS:
* The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities.
• PRIOR THERAPY:
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrolling on this study.
* No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study enrollment.
* Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry.
* Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry.
* Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry. For agents that have …