M.D. Anderson Cancer Center
The goal of this clinical research study is to learn if new anticancer drugs or drug combinations can help to control relapsed/refractory ES, DSRCT, or SRCS.
Primary Objective: Objective response rate (ORR) Determine the ORR endpoint (CR + PR) by the RECIST 1.1 criterion at three months for each substudy. To confirm sustained tumor shrinkage/disappearance, each patient's complete or partial response will be validated with a follow-up scan at least 4 weeks later, showing the same or better response (i.e., CR or PR for PR; CR for CR). Secondary Objectives: 1. Duration and depth of objective response. Assess the average duration of response (DOR) and depth of response (CR rate) for patients who achieve an objective response. 2. Median progression-…
Inclusion Criteria: Eligibility Criteria A. Age ≥ 10 years (Safety data from ≥3 adult patients must exist before enrolling children). B. 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. Exclusion Criteria: A.…
Given by injection
Arctuva estimate
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