Conditions: Bone Cancer Ewing's Sarcoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

Detailed description:

Arms:
arm 1: Regimen A alternating with Regimen B every 21 days

Regimen A:

* Cytoxan 1200mg/m2
* Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2
* Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg
* Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle

Regimen B:

* Irinotecan 50 mg/m2/day x 5 days
* Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free

Interventions: intervention 1: Irinotecan intervention 2: Vincristine intervention 3: Temozolomide intervention 4: Doxorubicin intervention 5: Cytoxan intervention 6: Pegfilgrastim
Intervention descriptions: intervention 1: 50 mg/m2/day x 5 days intervention 2: 2 mg/m2 to a maximum of 2 mg intervention 3: 100 mg/m2/day x 5 days followed by 2 weeks treatment-free intervention 4: Starting dose 75 mg/m2 to a maximum of 450mg/m2 intervention 5: 1200 mg/m2 intervention 6: 6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Protocol document: