Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT02210104
Eligibility Criteria:
Inclusion Criteria:
1. Histopathologic documentation of melanoma, synovial sarcoma or mixed round cell liposarcoma concurrent with the diagnosis of metastatic disease.
2. Tumor expression of NY-ESO-1 (2+ staining or \> 25%) by IHC.
3. Male or female subjects ≥18 years of age.
4. Expression of HLA-DPB1\*0401
5. Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of '0-1' .
6. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal
7. Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP.
8. Willing and able to give informed consent.
9. Adequate venous access - consider peripherally inserted central venous catheter (PICC) or central line
10. Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray or CT scan)
11. At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy, radiotherapy, or major surgery.
12. At least 6 weeks must have elapsed since the last nitrosoureas, mitomycin C and liposomal doxorubicin
13. Toxicity related to prior therapy must either have returned to \< or equal to grade 1, baseline, or been deemed irreversible
Exclusion Criteria:
1. Patients with active infections or oral temperature \> 38.2 C within 71 hours of Leukapheresis. The procedure may be deferred.
2. Patients with Hct \<30%, white blood count (WBC) \<2500/uL and platelets \<50,000 immediately prior to Leukapheresis. The procedure may be deferred.
3. Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix.
4. Complete blood count (CBC) and Chemistry profile prior to cyclophosphamide and T cell infusions: WBC \< 2000/uL Hct \< 24% or Hb \< 8 g/dL absolute neutrophil count (ANC) \< 1000 Platelets \< 50,000 Creatinine \> 3.0 x ULN AST/ALT \> 2.5 x ULN Bilirubin \> 3 x ULN
5. Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception. Women of childbearing potential with a positive pregnancy test within 3 days prior to entry.
6. Clinically significant pulmonary dysfunction, as determined by medical history and physical exam. Patients so identified will undergo pulmonary functions testing and those with FEV1 \< 2.0 L or DLco (corr for Hgb) \< 75% will be excluded.
7. Significant cardiovascular abnormalities as defined by any one of the following: Congestive heart failure, Clinically significant hypotension, Symptoms of coronary artery disease, Presence of cardiac arrhythmias on EKG requiring drug therapy,Ejection fraction \< 50 % (echocardiogram or MUGA).
8. Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening MRI or contrast CT).
9. Autoimmune disease: Patients with a history of Inflammatory Bowel Disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. Systemic Lupus Erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the Investigator to be unacceptable.
10. Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
11. Positive screening tests for HIV, Hep B, and Hep C. If positive results are not indicative of true active or chronic infection, the patient can be treated.
12. Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.
13. Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose.
14. No prisoners or children will be enrolled on this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02210104
Study Brief:
Protocol Section:
NCT02210104