SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sarcoma Alliance for Research through Collaboration
Study ID
NCT04067115
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
6 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Trabectedin 1 MG [Yondelis] — DRUG
    Patients with Ewing sarcoma will be administered trabectedin intravenously. Cycles are 21 days.
  • Irinotecan — DRUG
    Patients with Ewing sarcoma will be administered inirotecan intravenously. Cycles are 21 days.
  • tumor biopsy — DIAGNOSTIC_TEST
    Tumor tissue samples will be collected collected at two timepoints. The first biopsy will be prior to treatment. If a biopsy is not possible archival tissue may be submitted. A second tumor biopsy will be taken fro consenting patients when possible after the first administration of Trabectedin to evaluate the effect on the tumor cells.
  • 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging — OTHER
    Some patients will receive PET scans with the use of 18F-FLT, a radioactive tracer, performed at the National Institute of Health.

Study Details

This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment.

Key Dates

Start date
Jan 5, 2021
Status verified
Dec 2025
Primary completion
Apr 24, 2025
Completion
Apr 24, 2025

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Trabectedin and Irinotecan
    Trabectedin will be delivered by infusion on day 1 followed by 2 doses on irinotecan delivered by infusion for one hour on day 2 and day 4 of 21 day cycles. Some patients will receive an 18F-FLT Imaging scan prior to the first administration of trabectedin and once after administration of trabectedin.

Primary Outcome Measure

Phase I The recommended dose (RD) of trabectedin administered in combination with low dose irinotecan [ Time Frame: up to 36 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
National Cancer InstituteBethesdaMaryland20892-
Boston Children's Hospital / Dana Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48106-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
University of PennsylvaniaPhiladelphiaPennsylvania19105-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CANational Cancer Institute· Bethesda, MDBoston Children's Hospital / Dana Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MIChildren's Hospital of Philadelphia· Philadelphia, PAUniversity of Pennsylvania· Philadelphia, PA

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