This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas.
The names of the study drugs and biological agents involved in this study are:
* PEEL-224 (a type of Topoisomerase 1 inhibitor) * Vincristine (A type of vinca alkaloid) * Temozolomide (A type of alkylating agent) * Pegfilgrastim or Filgrastim (types of Myeloid growth factors)
Evaluable or measurable disease; and
Histologic diagnosis of sarcoma
RECIST measurable disease at study entry;
Histologic diagnosis consistent with Ewing sarcoma; and
Patients who have received prior treatment with PEEL-224.
Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT cohorts only.
Participants who are receiving any other anti-cancer agents for this condition.
Patients receiving strong P450 CYP1A2 and CYP3A4 inhibitors and/or inducers with 14 days of the first planned dose of PEEL-224. NOTE: levofloxacin is permitted and preferred over ciprofloxacin for patients needing a fluoroquinolone.
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Treatment groupsSee each treatment group below.
David S Shulman, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Peel Therapeutics Inc
Collaborator