28:I[164923,["/_next/static/immutable/chunks/0x-9rc1bm-510.js","/_next/static/immutable/chunks/0u73ovrok9bmr.js","/_next/static/immutable/chunks/3t9ifrnugpnlb.js","/_next/static/immutable/chunks/3gdp0tzp2t65u.js","/_next/static/immutable/chunks/0qexc5596g7lf.js","/_next/static/immutable/chunks/3nkl8euu6dycn.js","/_next/static/immutable/chunks/28p3k9kvs3dfa.js","/_next/static/immutable/chunks/04j_o97cgxn2x.js","/_next/static/immutable/chunks/18bybpoq919w1.js"],"ClinicalTrialDetail"] 27:T875,{"@context":"https://schema.org","@type":"FAQPage","mainEntity":[{"@type":"Question","name":"What are the potential benefits of participating in this trial compared to my current treatment?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma clinical trial (NCT00871481). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"What side effects should I expect from the treatments involved in this study?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma clinical trial (NCT00871481). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"How often will I need to come in for treatment and monitoring?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma clinical trial (NCT00871481). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"What happens if I experience side effects or my condition worsens during the trial?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma clinical trial (NCT00871481). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"Are there any other treatment options available to me outside of this trial?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma clinical trial (NCT00871481). Contact the study team or your healthcare provider for specific answers."}}]}25:["$","script","3",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"$27"}}] 29:T401,PRIMARY OBJECTIVES: I. Evaluate the safety and efficacy of adoptively transferred cytotoxic lymphocytes (CTL) targeting melanoma tumors combined with anti-CTLA4. II. Evaluate the influence of anti-CTLA4 (ipilimumab) on the duration of in vivo persistence and anti-tumor efficacy achieved following adoptive transfer of antigen-specific CTL. SECONDARY OBJECTIVES: I. Evaluate the influence of anti-CTLA4 on the induction of T cells to non-targeted tumor-associated antigens (antigen-spreading) following adoptive transfer antigen-specific CTL, and the correlation of these responses with clinical outcome. OUTLINE: Patients receive cyclophosphamide intravenously (IV) on day -2, therapeutic cytotoxic T lymphocytes IV over 30-60 minutes on day 0, low-dose aldesleukin subcutaneously (SC) twice daily (BID) on days 0-13, and ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.2a:T13cf,Inclusion Criteria: * 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 * 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 * 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 * Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography \[CT\] scan) * 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 Exclusion Criteria: * Patients with active infections or oral temperature \> 38.2 C within 72 hours prior to planned leukapheresis; the procedure may be deferred * Patients with hematocrit (Hct) \< 30%, white blood cells (WBC) \< 2500/uL and platelets \< 50,000 immediately prior to leukapheresis; the procedure may be deferred * 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 * White blood cell count (WBC) \< 2000/uL * Hematocrit (Hct) \< 24% or hemoglobin (Hb) \< 8 g/dL * Absolute neutrophile count (ANC) \< 1000 * Platelets \< 50,000 * Creatinine \> 3.0 x upper limit normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN * Bilirubin \> 3 x ULN * 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 * Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) \< 2.0 L or diffusion capacity of carbon monoxide (DLco) (corr for Hgb) \< 50% will be excluded * 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 electrocardiogram (EKG) requiring drug therapy * Ejection fraction \< 50 % (echocardiogram or multi gated acquisition \[MUGA\] scan) * Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening magnetic resonance imaging \[MRI\] or contrast CT) * 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 (Hep) B, and Hep C; if positive results are not indicative of true active or chronic infection, the patient can be treated * Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy * No prisoners or children will be enrolled on this study * 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 study26:["$","$L28",null,{"trial":{"nctId":"NCT00871481","briefTitle":"Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma","officialTitle":"Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma","briefSummary":"This phase I/II trial is studying the side effects of giving laboratory-treated T cells and ipilimumab together to see how well they work in treating patients with metastatic melanoma. Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving laboratory-treated T cells together with ipilimumab may kill more tumor cells","detailedDescription":"$29","overallStatus":"COMPLETED","phase":"PHASE1/PHASE2","studyType":"INTERVENTIONAL","conditions":["Recurrent Melanoma","Stage IV Melanoma"],"interventions":[{"type":"BIOLOGICAL","name":"ipilimumab","description":"Given IV"},{"type":"DRUG","name":"cyclophosphamide","description":"Given IV"},{"type":"PROCEDURE","name":"biopsy","description":"Optional correlative studies"},{"type":"BIOLOGICAL","name":"aldesleukin","description":"Given SC"},{"type":"OTHER","name":"immunohistochemistry staining method","description":"Correlative studies"},{"type":"GENETIC","name":"polymerase chain reaction","description":"Correlative studies"},{"type":"OTHER","name":"immunoenzyme technique","description":"Correlative studies"},{"type":"BIOLOGICAL","name":"therapeutic cytotoxic T lymphocytes","description":"Given IV"}],"keywords":null,"locations":[{"facility":"Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium","city":"Seattle","state":"Washington","country":"United States","zip":"98109","lat":47.60621,"lng":-122.33207}],"eligibilityCriteria":"$2a","minAge":18,"maxAge":null,"sex":"ALL","healthyVolunteers":false,"leadSponsor":"Fred Hutchinson Cancer Center","collaborators":["National Cancer Institute (NCI)"],"contacts":null,"startDate":"$D2009-02-01T00:00:00.000Z","completionDate":"$D2013-10-01T00:00:00.000Z","primaryCompletionDate":"$D2013-09-01T00:00:00.000Z","firstPostDate":"$D2009-03-30T00:00:00.000Z","lastUpdatePostDate":"$D2017-04-19T00:00:00.000Z","enrollmentCount":10,"enrollmentType":"ACTUAL","aiSummary":{"summary":"This clinical trial is testing a combination of laboratory-treated T cells and ipilimumab, a type of immunotherapy, to see how well they work in treating patients with metastatic melanoma, which is melanoma that has spread to other parts of the body. The goal is to see if this combination can help kill more tumor cells compared to standard treatments.","version":2,"mainIdea":"Safety and effectiveness of combined treatments","studyAbout":"This clinical trial is testing a combination of laboratory-treated T cells and ipilimumab, a type of immunotherapy, to see how well they work in treating patients with metastatic melanoma, which is melanoma that has spread to other parts of the body. The goal is to see if this combination can help kill more tumor cells compared to standard treatments.","comparedWith":"Ipilimumab","mayQualifyIf":["You have metastatic melanoma and are looking for new treatment options.","You are interested in innovative therapies that involve your own immune cells.","You have previously undergone treatment but are seeking additional options.","You are willing to participate in a study that may involve some hospital visits and monitoring."],"newTreatment":"Laboratory-treated T cells","lessRelevantIf":["You have active infections or significant health issues that could complicate treatment.","You are currently pregnant, nursing, or unable to use effective contraception if you are of childbearing potential."],"questionsToAsk":["What are the potential benefits of participating in this trial compared to my current treatment?","What side effects should I expect from the treatments involved in this study?","How often will I need to come in for treatment and monitoring?","What happens if I experience side effects or my condition worsens during the trial?","Are there any other treatment options available to me outside of this trial?"],"careConversation":"This study may be a good option for patients with metastatic melanoma who have not responded to other treatments. It's important to discuss with your oncologist how this trial fits into your overall treatment plan, including potential side effects, the logistics of participation, and your personal health goals. Your doctor can help you weigh the benefits and risks of this innovative approach against other available therapies.","worthDiscussingIf":["You have metastatic melanoma and are looking for new treatment options.","You are interested in innovative therapies that involve your own immune cells.","You have previously undergone treatment but are seeking additional options.","You are willing to participate in a study that may involve some hospital visits and monitoring."],"likelyWontQualifyIf":["You have active infections or significant health issues that could complicate treatment.","You are currently pregnant, nursing, or unable to use effective contraception if you are of childbearing potential."],"participationBullets":["Participants will receive laboratory-treated T cells and ipilimumab through intravenous (IV) infusions.","Cyclophosphamide will be given IV before the T cell treatment to prepare the body.","Aldesleukin will be administered subcutaneously (under the skin) for 13 days to help boost the immune response.","Participants will have regular check-ups to monitor their health and response to treatment."],"participationDetails":{"visitRhythm":"Visits will occur every few weeks for treatment and monitoring.","treatmentLength":"Expected duration is up to 13 days for the main treatment, with follow-up visits afterward.","participationCycles":"Ongoing monitoring after the initial treatment period."},"whatParticipatingInvolves":["Participants will receive laboratory-treated T cells and ipilimumab through intravenous (IV) infusions.","Cyclophosphamide will be given IV before the T cell treatment to prepare the body.","Aldesleukin will be administered subcutaneously (under the skin) for 13 days to help boost the immune response.","Participants will have regular check-ups to monitor their health and response to treatment."]},"aiSummaryGeneratedAt":"$D2026-05-02T19:25:47.265Z","id":"95ab9934-710e-4bfc-a254-0b2c7c197fd9","createdAt":"$D2026-03-23T06:05:38.724Z","updatedAt":"$D2026-05-02T19:25:47.265Z"}}]

What this study is about