[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-adrenal-cortical\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-adrenal-cortical":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053779","phase-1-study-of-preoperative-radiation-therapy-in-participants-with-resectable-recurrent-abdominal-adrenocortical-carcinoma-100053779",false,"NCT06487481","Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma","A Phase I Dose-escalation Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n* Age \\>= 18 years\n* Pathological confirmation of ACC by the Laboratory of Pathology, NCI. Note: Confirmation may be done from archival sample; fresh tissue is not required unless otherwise acquired for clinical purposes.\n* Measurable disease by RECISTv1.1. criteria at enrollment\n* Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC)\n* Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging)\n* Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments (e.g., liver parenchyma, lung\\[s\\], or bone\\[s\\]) must have disease that is amendable for a complete resection and\u002For catheter-based and\u002For radiation-based ablation.\n* Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. However, participants will be evaluated in separate cohorts based on mitotane use and, as enrollment is sequential, not all participants may be eligible for the study at all times. Note: Participants with a history of mitotane use may continue on study at the discretion of the treating investigator. Participants will not initiate mitotane on study.\n* Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment.\n* Performance Status (ECOG) 0-2\n* Adequate organ function, including:\n\n  * Hemoglobin \\>= 9.0 gm\u002FdL\n  * ANC \\>= 1,500\u002Fmm\\^3\n  * Platelets \\>= 75,000\u002Fmm\\^3\n  * AST and ALT \\\u003C= 3 x Upper Limit Normal (ULN)\n  * Bilirubin \\\u003C= 2 x ULN\n  * Creatinine within normal institutional limits or creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR.\n* Individuals of childbearing potential must agree to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) prior to RT and continue until at least 4 months following cytoreduction surgery.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing prior to RT and continue until at least 4 months following cytoreductive surgery.\n* Ability of participant to understand and willingness to sign a written informed consent document\n* Participants must agree to co-enroll in tissue collection protocol 09C0242 \"Prospective comprehensive molecular analysis of endocrine neoplasms.\"\n\nEXCLUSION CRITERIA:\n\n* Primary ACC or suspicious\u002Findeterminate adrenal tumor without pathological confirmation\n* Prior abdominal radiation therapy\n* Participants who have received chemotherapy, immunotherapy, investigational therapy, or radiotherapy treatment within the last 4 weeks prior to starting treatment and\u002For have not recovered from toxicities to less than grade 2 CTCAE.\n* Infection requiring parenteral antibiotics\n* Suspected or proven ACC peritoneal metastasis\n* Pre-existing known or suspected radiation sensitivity syndromes\n* Prohibitive condition(s) to diagnostic laparoscopy\n* Participants who have an unacceptable risk for a major surgical procedure such as participants with high risks for major cerebro-cardiovascular (such as those who had doxorubicin exposure as based on screening echocardiogram and ECG) and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator.\n* Participants receiving other investigational therapies\n* Participant pregnancy\n* Active systemic infections, coagulation disorders, or other major medical illnesses such as uncontrolled diabetes mellitus, uncontrolled hypertension (persistently grade 2 or worse), active severe cerebro-cardio-pulmonary diseases, and acute major organ dysfunction.\n* Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery.\n* Evidence at screening of or currently active CNS metastasis within 6 months of RT; participants with history of treated brain metastases with intracranial recurrence within 6 months prior to treatment. Note: Participants with any signs or symptoms suggestive of previously undiagnosed brain metastasis at screening or with a history of brain metastasis should receive imaging at screening; otherwise, imaging is not required.\n* HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy\n* Participants who have a history of another primary malignancy from which the participant has been disease-free for \\\u003C 3 years at the time of enrollment.","ALL","18 Years","120 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nAdrenocortical carcinoma (ACC) is a rare cancer of the adrenal glands. ACC often returns after tumors are removed with surgery. Less than 35% of people with ACC survive 5 years after diagnosis.\n\nObjective:\n\nTo test a new type of external beam RT before surgery in people with ACC.\n\nEligibility:\n\nPeople aged 18 years and older with ACC that came back after treatment but may be safely removed with surgery.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have imaging scans. A small sample of tumor tissue may be collected if one is not available. They will undergo laparoscopy: Small incisions will be made in the abdomen so that a thin tube with a light and camera can be inserted to view the organs.\n\nRT comes from a machine that aims radiation at tumors. Participants will receive preoperative RT in daily fractions over approximately 2-3 weeks, followed by a planned surgical resection about 4 weeks after the completion of RT. Visits will last 30 to 60 minutes.\n\nParticipants will undergo surgery to remove their tumors about 4 weeks after they finish RT. They will stay in the hospital 1 to 3 weeks after surgery.\n\nParticipants will have follow-up visits for 10 years after surgery.",[27,28,29,30,31],"Adrenocortical Carcinoma (ACC)","Recurrent Adrenocortical Carcinoma (ACC)","Recurrent Abdominal Adrenocortical Carcinoma (ACC)","Carcinoma, Adrenocortical","Carcinoma, Adrenal Cortical",[33,34,35,36,37,38,39,40,41,42],"external beam radiation therapy (EBRT)","abdominal adrenocortical carcinoma (ACC)","preoperative radiation","Mitotane","Maximum Tolerated Dose (MTD)","Surgical Resection","in-field intraabdominal progression-free survival (PFS)","out-of-field intraabdominal progression-free survival (PFS)","DNA damage repair markers","oxidative stress response","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":21},"2026-07-16",{"date":51,"type":21},"2040-12-01",{"name":53,"class":54},"National Cancer Institute (NCI)","NIH",1,{"id":57,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":25,"conditions":60,"keywords":61,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":55},"100553545",{"count":20,"type":21},[24],[27,28,29,30,31],[33,34,35,36,37,38,39,40,41,42],"2026-07-01",{"date":64,"type":47},"2026-07-02",{"date":66,"type":21},"2026-07-07",{"date":51,"type":21},{"name":53,"class":54},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":55},"100519282","phase-1-a-first-in-human-phase-i-trial-with-antibody-drug-conjugate-adct-701-in-neuroendocrine-tumors-carcinomas-and-malignant-peripheral-nerve-sheath-tumors-100519282","NCT06041516","A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST).\n* Locally advanced, unresectable or metastatic disease (as confirmed by a radiological evaluation)\n* Participants must have measurable disease per RECIST 1.1.\n* Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). Note: Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic\n\nchemotherapy is felt to be in the best interest for the patient by the local investigator and treating investigator will also be eligible.\n\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Adequate hematologic function as follows:\n\n  * Leukocytes \\>= 3,000\u002Fmicroliter\n  * Absolute neutrophil count (ANC) \\>= 1,200\u002Fmicroliter (off-growth factors for 72 hours prior to treatment initiation)\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL with no blood transfusion within 2 weeks prior to treatment initiation\n  * Platelets \\>= 100,000\u002Fmicroliter with no platelet transfusion within 1 week.\n* Adequate renal and hepatic function as follows:\n\n  * Creatinine clearance (CrCl) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (calculated CrCl (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or calculated eGFR provided by a laboratory))\n  * Total bilirubin \\\u003C= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \\\u003C= 3.0 x ULN\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 2.5 x ULN, (unless liver metastases are present, then values must be \\\u003C= 5 x ULN).\n* Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load.\n* Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral deoxyribonucleic acid (DNA) load must be \\\u003C2000 IU\u002FmL.\n* Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \\>= 200 cells per cubic millimeter.\n* Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 9.5 months after the last dose of the ADCT-701 (restriction period).\n\nIndividuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 6.5 months after the last dose of the ADCT-701.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6.5 months after study treatment discontinuation.\n* Participants or legally authorized representative (LAR) must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and\u002For radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.\n* Participants taking any herbal supplements within 14 days prior to treatment initiation.\n* Participants who have wound dehiscence from prior surgeries.\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requires drainage or is associated with shortness of breath) at screening.\n* Active infection requiring systemic antibiotic therapy at screening.\n* Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target international normalized ratio (INR) \\> 2 at screening.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.\n* An active autoimmune disease. Note: Participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\\\u003C= the equivalent of prednisone 10 mg\u002Fday), or other mild autoimmune disorders (Type 1 diabetes, eczema, vitiligo, alopecia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, adrenal insufficiency due to Addison's disease, hypothyroidisms due to Hashimoto's thyroiditis, hyperthyroidisms due to Graves disease, Sjogren s syndrome, celiac disease, pernicious anemia) not requiring immunosuppressive treatment are eligible.\n* Congenital long QT syndrome, or a corrected QTcF interval of \\>=480 ms, at screening (unless secondary to the pacemaker or bundle branch block).\n* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care.\n* Live vaccine administration within 30 days prior to treatment initiation.\n* Pregnant individuals (confirmed by Beta-Human Chorionic Gonadotropin \\[Beta-HCG\\] serum or urine pregnancy test) performed at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.",{"count":76,"type":21},70,[24],"Background:\n\nNeuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed.\n\nObjective:\n\nTo test a new drug, ADCT-701, in people with NENs.\n\nEligibility:\n\nAdults aged 18 and older with NENs.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of heart functioning. Their ability to perform normal daily activities will be tested. A biopsy may be needed: A sample of tissue will be removed from the tumor.\n\nADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive the drug treatment on the first day of 21-day treatment cycles. They will visit the clinic a total of 10 times during the first two cycles. After that, they will visit the clinic 2 times during each cycle. Imaging scans, blood draws, heart function tests, and other tests will be repeated during study visits. Each visit will last up to 8 hours.\n\nParticipants may continue receiving treatment with the study drug for up to 2 years.\n\nAfter treatment ends, participants will have follow-up clinic visits 4 times in 4 months. They will have a physical exam, with heart and blood tests, at each visit. After that, they will have follow-up clinic visits every 9 weeks; these visits will include imaging scans.\n\nFollow-up visits will continue for up to 5 years after treatment began....",[80,81,82,30,31],"Neuroendocrine Carcinomas","Neuroendocrine Tumors","Carcinoma, Neuroendocrine",[84,85,86,87,88,89,90],"Pheochromocytoma","Neuroblastoma","Neuroendocrine Tumor","Neuroendocrine carcinoma","Neuroendocrine neoplasms","Paraganglioma","Adrenocortical Carcinoma","2026-06-12",{"date":93,"type":47},"2026-06-15",{"date":95,"type":47},"2024-06-17",{"date":97,"type":21},"2029-10-30",{"name":53,"class":54}]