Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma

NCT03397186 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-09-10

No results posted yet for this study

Summary

This research trial studies the immune changes following trabectedin in patients with sarcoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Analyzing tumor tissue may help to understand the changes in immune cells in or around the tumor or if there is an increase in immune cells in the tumor after receiving trabectedin.

Conditions

  • Myxoid Liposarcoma
  • Round Cell Liposarcoma
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Metastatic Soft Tissue Sarcoma
  • Unresectable Soft Tissue Sarcoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Trabectedin

Given as standard of care

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Janssen Pharmaceuticals

    collaborator INDUSTRY
  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Seth Pollack · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2021-01-01
Completion
2021-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397186 on ClinicalTrials.gov