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Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma

NCT02408016 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-09-13

Study results available
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Summary

This phase I/II trial studies the side effects and best dose of genetically modified T cells in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell from patients, called T cells, and modifies their genes in the laboratory so that they are programmed to find cells with WT1 and kill them. The T cells are then given back to the patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may help the body build an immune response to kill tumor cells.

Conditions

  • Advanced Pleural Malignant Mesothelioma
  • HLA-A*0201 Positive Cells Present
  • Recurrent Non-Small Cell Lung Carcinoma
  • Recurrent Pleural Malignant Mesothelioma
  • Stage III Non-Small Cell Lung Cancer AJCC v7
  • Stage III Pleural Malignant Mesothelioma AJCC v7
  • Stage IIIA Non-Small Cell Lung Cancer AJCC v7
  • Stage IIIB Non-Small Cell Lung Cancer AJCC v7
  • Stage IV Non-Small Cell Lung Cancer AJCC v7
  • Stage IV Pleural Malignant Mesothelioma AJCC v7
  • WT1 Positive

Interventions

BIOLOGICAL

Aldesleukin

Given SC

BIOLOGICAL

Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes

Given IV

DRUG

Cyclophosphamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Sylvia Lee · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-22
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02408016 on ClinicalTrials.gov