At a glance
ClinicalIndex Comparison Record- ✓Age 1–21 years with histologically confirmed advanced solid tumor or CNS tumor (Part 1) or specifically neuroblastoma, high-grade gliomas, or rhabdomyosarcoma (Part 2)
- ✓Disease must be recurrent, refractory to standard therapy, or standard therapy unavailable (Part 1)
- ✓Part 2: Measurable disease or (for neuroblastoma) evaluable disease by MIBG scan
- ✓Histological confirmation waived for brain stem gliomas and optic pathway tumors (Part 1) and brain stem gliomas (Part 2)
- ✕Receiving enzyme-inducing anticonvulsants
- ✕Pulmonary hypertension or pneumonitis
- ✕Active infection or serious intercurrent illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors
In Brief
A Phase 2 clinical trial evaluating Torisel for Adenocarcinoma and Neoplasms. Completed, enrolled 71 participants across 30 sites in 7 countries.
Detailed Summary
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)
Study Details
Timeline
Interventions
60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.