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A phase I study of vinorelbine, cyclophosphamide and Rapamycin for recurrent malignancies in children (Other ID's: U1111-1141-5343)
Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)
This study will evaluate the safety and tolerability of combining the 3 drugs, vinorelbine, cyclophosphamide, and Rapamycin, in children with recurrent/refractory malignant disease.
The following histologies are eligible: All brain tumours, Rhabdomyosarcoma, Soft tissue sarcomas, Osteogenic sarcoma, Ewing sarcoma, Neuroblastoma, WilmsÆ’?? tumour.
Who is it for?
You (or your child) may be eligible to join this study if you/they are aged less than 22 years of age and have been diagnosed with any of the following solid tumours/malignancies: all brain tumours, Rhabdomyosarcoma, Soft tissue sarcomas, Osteogenic sarcoma, Ewing sarcoma, Neuroblastoma, WilmsÆ’?? tumour. The disease must have either relapsed or not responded to initial therapy. Trial details All participants in this trial will undergo treatment with a combination of the three drugs vinorelbine, cyclophosphamide, and rapamycin.
Cyclophosphamide is administered one per day orally, rapamycin is administered twice per day orally, and vinorelbine will be administered on days 1, 8 and 15 of each 28 day cycle intravenously (i.e. into the vein). This cycle will be repeated every 28 days. If the initial dose level is tolerated by patients, then it will be increased for the next patient group in order to determine the optimum dose combination for both heavily pre-treated and less heavily pre-treated participants. In addition to evaluating the toxicity of this drug regimen and determining a dosage range, the potential efficacy of the regimen will be assessed.
All participants will be regularly monitored and assessed for a period of up to 5 years in order to evaluate the safety and tolerability of this treatment.