A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma
Basic Trial Information
|Phase I||Treatment||Active||4 to 55||NCI, Pharmaceutical / Industry||ADP 04511|
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
- 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.
- 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
- 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.
- 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
- National Cancer Institute
Memorial Sloan-Kettering Cancer Center
Sandra D'Angelo, MD
Sandra D'Angelo, MD
Children's Hospital of Philadelphia
Christine Strait, BS
Stephan A. Grupp
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01343043
ClinicalTrials.gov processed this data on April 02, 2015
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.