Autologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery

Patients for whom we are unable to generate NY-ESO-1 specific cells

Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry

Serum creatinine \> 1.5 mg/dL or glomerular filtration rate \< 50

Significant hepatic dysfunction (serum glutamic oxaloacetic transaminase \[SGOT\] \> 150 IU or \> 3x upper limit of normal \[ULN\])

Bilirubin \> 1.6 mg/dL

Prothrombin time (PT) \> 1.5 x control

Most patients with metastatic sarcoma will have pulmonary metastasis and it is expected that the majority will have some mild to moderate baseline shortness of breath; these patients will be allowed on study so long as their Eastern Cooperative Oncology Group (ECOG) performance status is 1; patients with severe pulmonary dysfunction (\>= grade 3 respiratory disorders as defined by Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]4) will not allowed on study until their condition improves; however, patients who have recently experienced a decrease in their pulmonary function will be required to undergo pulmonary function testing; patients with a forced expiratory volume in one second (FEV1) \< 1.5L or diffusing capacity of carbon monoxide (DLco) (corrected \[corr\] for hemoglobin \[Hgb\]) \< 50% will be excluded; patients with a reversible cause of pulmonary dysfunction may undergo repeat testing and enroll if their pulmonary function tests (PFT's) meet criterion

All patients must have an echocardiogram (echo) showing ejection fraction (EF) \> 50% and normal troponin and creatine kinase (CK) MB (echo may be done at the time of stress test as a stress echo); furthermore the following significant cardiovascular abnormalities will be excluded:

* Active, symptomatic congestive heart failure

* Clinically significant hypotension

* Symptoms of coronary artery disease

* Presence of cardiac arrhythmias on EKG requiring drug therapy which has not been stable for at least 6 months

Patients with symptomatic untreated brain metastasis or asymptomatic untreated brain metastasis \> 1 cm will not be allowed to participate; additionally, patients with five or more untreated brain metastasis under 1 cm will not be allowed to participate; treatment may include surgery or stereotactic radiation at the discretion of the patient's treatment team; patients must be off steroids when starting therapy

Patients with active infections or oral temperature \> 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy

Chemotherapeutic agents (standard or experimental or other immunosuppressive therapies) less than 3 weeks prior to T cell therapy; (patients with bulky disease may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3 weeks prior to T cell infusion); patients may receive palliative radiation therapy two weeks prior to T cell infusion

Current treatment with steroids

Patients must not be receiving any other experimental drugs within 3 weeks of the initiation of treatment and must have recovered from all side effects of such therapy

Patients who were not negative for hepatitis B virus (HBV), hepatitis C virus (HCV) at the time of their leukapheresis on 1246 or 2365 must be retested to be sure they are PCR negative

Patients with a history of myocarditis, pericarditis, endocarditis

Autologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery

What this study is about

Autologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery

What this study is about