NCT03397186

Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma

An Analysis of the Changes in the Sarcoma Tumor Immune Microenvironment Following Trabectedin

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Percentage of tumor tissue in pre- and post-treatment biopsies comprised of T-cells, as determined by flow cytometry. SECONDARY OBJECTIVES: I. To explore additional potential biomarkers including: numbers of tumor associated macrophage (TAM) in tumor II. To explore additional potential biomarkers including: phenotype (classically activated macrophages \[M1\] versus \[vs\] alternatively activated macrophages \[M2\]) as characterized by CD163, CD115, CD206 on infiltrating TAM. III. To explore additional potential biomarkers including: phenotype of T cells infiltrating tumor (CD4, CD8, markers of CD4 phenotype including FoxP3 and memory). IV. To explore additional potential biomarkers including: expression T cell inhibitory markers (PD-1, CTLA-4, TIM3). V. To explore additional potential biomarkers including: recognition of autologous tumor by expanded tumor infiltrating lymphocyte lines. VI. To explore additional potential biomarkers including: in tumor infiltrating lymphocyte (TIL) expanded from myxoid/round cell liposarcomas, recognition of cancer testis antigens. OUTLINE: Patients undergo a biopsy at baseline and then receive trabectedin for up to 4 cycles. Beginning 1 week after completion of cycle 2 and prior to cycle 3, patients undergo a second biopsy. Patients who achieve clinical benefit (complete response \[CR\], partial response \[PR\], stable disease \[SD\]) after the first post-treatment scan and who continue trabectedin for 4 cycles undergo a third biopsy after cycle 4. After completion of study, patients are followed up for 30 days.

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

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Trabectedin	Given as standard of care

Timeline

• Start date: 2018-06-19
• Primary completion: 2021-01-01
• Completion: 2021-05-01
• First posted: 2018-01-11
• Last updated: 2019-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study