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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
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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 side- measure 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) VAdCA alt with I/E R A N D O M I Z 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 • Stage 1, clinical group I/II & orbital group III, stage 2 clinical group I, II • 4 more VA courses for subset B • 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
RhabdomyosarcomaPatients 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 • 7 cycles ID • Infantile fibrosarcoma, Mignon Loh PI • 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