Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas

Inclusion criteria

• ✓Patients in all cohorts must have relapsed or refractory disease after standard therapy.
• ✓Patients must have:
• ✓-Hematologic Requirements for Subjects with Bone Marrow Involvement by Disease:
• ✓-Adequate Renal Function: Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or A serum creatinine based on age/sex as follows:
• ✓--≥ 16 years, Maximum Serum Creatinine (mg/dL): Male 1.7, Female 1.4
• ✓-Adequate Liver Function:
• ✓Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted above. Patients must meet the following minimum washout periods prior to enrollment:
• ✓For patients with metastatic disease to the CNS enrolling to the phase 1 portion of the trial or the "other sarcoma" cohort, any baseline neurologic deficits (including seizure) must be stable for at least one week prior to study enrollment. Patients with CNS metastatic disease receiving corticosteroids must be on a stable or decreasing dose at time of study entry.