Immune Changes Following Trabectedin in Patients With Metastatic or

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03397186
Study type	Interventional
Source	Fred Hutchinson Cancer Research Center
Contact
Status	Withdrawn
Phase	Phase 2
Start date	June 19, 2018
Completion date	May 1, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms