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A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentActive4 to 55NCI, Pharmaceutical / IndustryUPCC 04511
NCT01343043

Trial Description

Summary

The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and the NYESO T cells on patients with metastatic and recurrent synovial sarcoma.

Further Study Information

Design

  • Patients will undergo apheresis at the enrolling institution. Fresh PBMC will be shipped to University of Pennsylvania and shipped back to the enrolling institution.
  • Patients will undergo lymphodepletion with denileukin diftitox, fludarabine and cyclophosphamide, then infusion of NY-ESO-1 genetically engineered T cells on Day 0.
  • Patients will be monitored for toxicity, antitumor effects and immune endpoints.
  • Patients with a PR or SD may receive a 2nd cycle no earlier than 60 days following completion of the first cycle if eligibility criteria are met. For patients with progressive disease, a 2nd cycle that includes high dose aldesleukin administered beginning on the day of T cell infusion may be administered no earlier than 60 days following completion of the first cycle if eligibility criteria are met.

Eligibility Criteria

Inclusion Criteria:

  • Synovial sarcoma that has been treated with standard chemotherapy containing doxorubicin and remains: unresectable or metastatic or progressive/persistent or recurrent disease
  • Measurable disease
  • Synovial sarcoma and NY-ESO-1+ expression by immunohistochemistry
  • HLA-A2+
  • Age 4 to less than or equal to 55. NIH 4 to less or equal to 35. Washington University greater than or equal to 18.
  • Weigh more than 18 kg
  • All previous cytotoxic chemotherapy, monoclonal antibody therapy, immune, biologic or molecularly targeted therapy must be completed at least 3 weeks prior to study entry.
  • Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less
  • Performance Status. ECOG 0, 1 or 2 for age greater than 10 years. Lansky greater than or equal to 60 for children less than or equal to 10 years of age.
  • Life expectancy greater than 3 months
  • Left ventricular ejection fraction greater than or equal to 40% or fractional shortening greater than or equal to 28%
  • T.bilirubin < 2 mg/dl (Patients with Gilbert Syndrome exempt)
  • AST, ALT less than or equal to 2.5 x upper limit of normal
  • ANC > 750/mm3
  • Platelets > 75,000/mm3
  • Age-adjusted normal serum creatinine or a creatinine clearance greater than or equal to 60 ml/min/1.73m2
  • Ability to give informed consent for patients greater than 18 years of age. For patients less than 18 years of age the legal guardian must give informed consent.
  • Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment.

Exclusion Criteria:

  • Clinically significant systemic illness that in the judgment of the PI would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.
  • Untreated CNS metastasis
  • Previous treatment with genetically engineered NY-ESO-1 specific T cells. Previous vaccine therapy is not an exclusion criteria.
  • Lactating or pregnant females
  • Active HIV, HBV or HCV infection
  • Patients who require systemic corticosteroid or other immunosuppressive therapy. Immunosuppressive therapy must be stopped at least 14 days prior to cell infusion.

Trial Contact Information

Trial Lead Organizations/Sponsors

Adaptimmune LLC

National Cancer Institute

Crystal MackallPrincipal Investigator

Stephan Grupp, MD, PhDPrincipal Investigator

Crystal Mackall, MDPh: 301-402-5940
  Email: mackallc@mail.nih.gov

Trial Sites

U.S.A.
Maryland
  Bethesda
 National Institutes of Health
 Crystal Mackall, MD Ph: 301-402-5940
  Email: mackallc@mail.nih.gov
 Melinda Merchant, MD, PhD Ph: 301-443-7955
  Email: melinda.merchant@mail.nih.gov
Pennsylvania
  Philadelphia
 Children's Hospital of Philadelphia
 Christine Strait, BS Ph: 267-425-5837
  Email: straitc@email.chop.edu
 Stephan Grupp, MD, PhDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01343043
ClinicalTrials.gov processed this data on December 04, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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