RAPID: Phase 2 Platform Trial Of Promising Drugs For AYA Patients With R/R Ewing Sarcoma & DSRCT

Más betegség

• Uncontrolled or severe cardiac, neurologic, pulmonary, pancreatic, renal, or liver disease.

Laborértékek

• No known personal family history of Long QT syndrome C. History of organ transplant (other than autologous stem cell transplant for cancer), active pneumonitis, myelodysplastic syndrome, or leukemia (acute or chronic) D. Immune or auto-immune-related disorders requiring treatment (treatment for eczema is allowed) E. Investigational agents within 7 days of starting study treatment. F. Major surgery within 28 days before treatment consent (Treatment cannot start with a persistent open wound) G. Leptomeningeal disease or untreated brain metastases. H. Unable to safely hold anticoagulant medication, if taken, for biopsy. I. Psychiatric illness/social situations that would limit compliance with study requirements.

Egyéb

• Prisoners or participants who are legally institutionalized.

• Eligibility Criteria
• Age ≥ 10 years (Safety data from ≥3 adult patients must exist before enrolling children).
• Must have relapsed or chemo-refractory ES, DSRCT, or SRCS. C. Must have received at least 2 prior chemotherapy regimens (typically VIDE or VDC/IE) D. Measurable disease by RECIST (i.e., tumor ≥1 cm in minimal dimension) E. ECOG performance status is 0-2 for adults (Karnofsky/Lansky score ≥60 for children <16 years of age) F. >1 week washout period from any investigational agent and resolution of drug-related AE/SAE to ≤ grade 2.