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Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies

NCT01697527 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-11-24

No results posted yet for this study

Summary

This phase II trial will examine whether genetically reprogramming a patient's disease fighting white blood cells may build an immune response to kill cancer cells that express the NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein and may help to stimulate the engineered immune response to tumor cells.

Conditions

  • Malignant Neoplasm

Interventions

BIOLOGICAL

aldesleukin

Given SC

DRUG

fludarabine phosphate

Given IV

DRUG

cyclophosphamide

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

BIOLOGICAL

NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL

Undergo NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL

BIOLOGICAL

dendritic cell vaccine therapy

Given NY-ESO-1-157-165 peptide pulsed dendritic cell vaccine ID

RADIATION

fludeoxyglucose F 18

Undergo PET scan using \[18F\] FDG tracer

PROCEDURE

positron emission tomography

Undergo fludeoxyglucose F18 PET

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Antonio Ribas, MD, PhD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-02
Primary Completion
2026-11-02
Completion
2027-11-02

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 NCT01697527 on ClinicalTrials.gov