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Children’s Oncology Group Sarcoma Plans Holcombe E. Grier MD For the Children’s Oncology Group Lots of Folks Involved Bone Sarcoma Committee Neyssa Marina- chair Rich Gorlick- vice chair Mark Bernstein- previous chair of bone sarcoma committee Mark Krailo- biostatistician Soft Tissue Sarcoma Committee William Meyer- chair Doug Hawkins- vice chair James Anderson- biostatistician Plan: Present Upfront and Relapsed Trials for Following Diseases Bone tumors Osteosarcoma Ewing Sarcoma Soft Tissue Sarcomas Rhabdomyosarcoma Non-Rhabo STS Infantile fibrosarcoma Desmoid tumor Osteosarcoma: Up front trials Patients without metastases: Euramos (Neyssa Marina USA chair) Metastatic: Recently completed trial of feasibility of adding transtuzumab (herceptan) to MAP (David Ebb) Plan to incorporate bisphosfonates (zolendronic acid) into MAP background Osteosarcoma-Treatment at First Pulmonary Relapse: Inhaled GM-CSF (Arndt PI) For patients with bilateral mets Resect one side 2 cycles GM-CSF Resect other sidemeasure Fas/FasL in tumor Also using for patients with unilateral disease Disease free interval will be measured Ewing Sarcoma: Upfront treatment Patients without metastases Still analyzing dose compression trial (Rick Womer) Next trial will incorporate topotecan/cyclophosphamide pair (Mason Bond) Patients with metastases EuroEwings: pulmonary mets (Doug Hawkins) Metranomic therapy (Judy Felgenhauer) Schema: AEWS0031 (Mason Bond) R A N D O M I Z E VAdCA alt with I/E Duration 48 weeks VAdCA alt with I/E alt with V/T/C Duration 48 weeks Metronomic Therapy for Patients Presenting with Extensive Metastases PI Felgenhauer Standard therapy backbone (Vcr, Dox, Cyclophos alt with ifosfamide/etoposide) Overlay of Celecoxib 250 mg/m2 per day Vinblastine 1 mg/m2 three times weekly Objective is feasibility of regimen, estimation of EFS, assessment of surrogate angiogen. markers Will reach accrual soon Concept for Next Trial for Patients with Extensive Metastases Pilot to look at addition of irinotecan/temozolomide to standard therapy Goal will be feasibility Also considering bevacizumab randomization Rhabdomyosarcoma-Up Front Patients Without Metastases Low Risk (David Waterhouse PI) Emb only 4 courses VAC for all patients; Subset A stops 4 more VA courses for subset B Stage 1, clinical group I/II & orbital group III, stage 2 clinical group I, II Stage 1, group III not orbit or stage 3 clinical group I/II Intermediate risk (Doug Hawkins PI) Randomize VAC vs VAC alternating with Vincristine/Irinotecan Rhabdomyosarcoma Patients Presenting with Metastases Brenda Weigel PI Intensive regimen Rx Vincristine, irinotecan window VDC IE Iriniotecan/vcr during radiation NRSTS NRSTS: Risk based rx, Sherry Spunt PI Infantile fibrosarcoma, Mignon Loh PI 7 cycles ID VAC, stopping C before infertility likely Convert non-operable to operable Desmoid tumors, Steve Skapek PI f/u to mtx/vbl study Sulindac and tamoxifen Biology Trials Collecting specimens at diagnosis for each tumor type Collection process has been extremely successful Committees review concepts for use of the tissue