Clinical Trials (PDQ®)
|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 Lead Organizations/Sponsors
Adaptimmune LLCNational Cancer Institute
|Crystal Mackall||Principal Investigator|
|Stephan Grupp, MD, PhD||Principal Investigator|
|Crystal Mackall, MD||Ph: 301-402-5940|
|National Cancer Institute|
|Crystal Mackall, MD||Ph: 301-402-5940|
|Melinda Merchant, MD, PhD||Ph: 301-443-7955|
|Memorial Sloan-Kettering Cancer Center|
|Sandra D'Angelo, MD||Ph: 646-888-4159|
|Sandra D'Angelo, MD||Principal Investigator|
|Children's Hospital of Philadelphia|
|Christine Strait, BS||Ph: 267-425-5837|
|Stephan A. Grupp||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01343043
ClinicalTrials.gov processed this data on April 02, 2015
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