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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT02027935
Eligibility Criteria:
Inclusion Criteria:
* ELIGIBILITY FOR ENROLLMENT
* Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease
* Expression of human leukocyte antigen (HLA)-A2
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of '0-1' at screening visit
* 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 of 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
* 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
* Willing and able to give informed consent
* Adequate venous access - consider peripherally inserted central catheter (PICC) or central line
* Evaluation of v-raf murine sarcoma viral oncogene homolog B (BRAF)V600 mutation status
* Measurable tumor (by Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria)
* Melan-A (MART) 1 or solute carrier family 45, member 2 (SLC45A2) (+) staining results; (if patients have not had staining test in the past, the test will be run after patient consent is obtained, but before enrollment)
* ELIGIBILITY FOR TREATMENT (INCLUDES CYCLOPHOSPHAMIDE, T CELL, ANTI-CTLA4 INFUSIONS AND SC IL-2)
* ECOG/Zubrod performance status of '0-1'
* At least 4 weeks must have elapsed since the last chemotherapy, radiotherapy or major surgery; at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin; if started before T-cell administration, ipilimumab infusions must be least 21 days apart
* Toxicity related to prior therapy must either have returned to =\< grade 1, baseline, or been deemed irreversible
* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 8 weeks after study drug is stopped
* Willing and able to give informed consent.
Exclusion Criteria:
* EXCLUSION FOR ENROLLMENT
* 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
* 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
* Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening magnetic resonance imaging \[MRI\] or contrast computed tomography \[CT\])
* No signs or symptoms of CNS metastases (mets) within the last 30 days (from enrollment evaluation)
* No single lesion larger than 1 cm
* No more than 5 lesions
* 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
* 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
* Positive screening tests for human immunodeficiency virus (HIV), hepatitis B (hep B), and hepatitis C (hep C) (referencing blood draw at leukapheresis screening); if positive results are not indicative of true active or chronic infection, the patient can be treated
* White blood cells (WBC) =\< 1000/uL
* Hematocrit (Hct) =\< 24% or hemoglobin (Hb) =\< 8 g/dL
* Absolute neutrophil count (ANC) =\< 500
* Platelets =\< 50,000
* Creatinine \>= 3.0 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>= 2.5 x ULN
* Bilirubin \>= 3 x ULN
* Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy
* Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
* Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study
* EXCLUSION CRITERIA FOR TREATMENT
* WBC =\< 1000/uL (prior to cyclophosphamide and T cell infusions)
* Hct =\< 24% or hemoglobin =\< 8 g/dL (prior to cyclophosphamide and T cell infusions)
* ANC =\< 500 (prior to cyclophosphamide and T cell infusions)
* Platelets =\< 50,000 (prior to cyclophosphamide and T cell infusions)
* Creatinine \>= 3.0 x ULN (prior to cyclophosphamide and T cell infusions)
* AST/ALT \>= 2.5 x ULN (prior to cyclophosphamide and T cell infusions)
* Bilirubin \>= 3 x ULN (prior to cyclophosphamide and T cell infusions)
* 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.
* Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.
* Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose.
* Patients may not be on any other treatments for their cancer aside from those included in the protocol. Patients may not undergo another form of treatment concurrently with this study.
* Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening MRI or contrast CT):
* No signs or symptoms of CNS mets within the last 30 days (from enrollment evaluation).
* No single lesion larger than 1cm
* No more than 5 lesions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02027935
Study Brief:
Protocol Section:
NCT02027935