[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-non-muscle-invasive-bladder-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-non-muscle-invasive-bladder-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100592949","phase-3-testing-the-addition-of-an-anti-cancer-drug-gemcitabine-to-usual-treatment-bcg-alone-in-people-whose-non-muscle-invasive-bladder-cancer-nmibc-came-back-after-prior-bcg-therapy-100592949",false,"NCT07000084","Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy","GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer","GAIN-BCG","Inclusion Criteria:\n\n* Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis\u002Fcarcinoma in situ \\[CIS\\] only disease) within 120 days prior to randomization\n* Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes\u002Fvariant histologies are allowed so long as there is a predominantly urothelial component.\n\n  \\* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed\n* All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted).\n\n  \\* If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease\n* All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT\n* Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease\n\n  * Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence\u002Fsuspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG.\n  * Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient.\n  * BCG-exposed NMIBC criteria is defined as:\n\n    * Any high grade NMIBC recurrence within 24 months of induction only BCG, or\n    * A high grade papillary NMIBC (Ta\u002FT1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or\n    * A high-grade CIS (with or without Ta\u002FT1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG.\n  * Patient must not have BCG-unresponsive NMIBC, defined as:\n\n    * Persistent or recurrent high-grade papillary NMIBC (Ta\u002FT1) \\\u003C 6 months of \"adequate\" BCG, or\n    * A high-grade CIS (with or without Ta\u002FT1 papillary disease) recurrence \\\u003C 12 months of \"adequate\" BCG, or\n    * A high grade T1 recurrence at the first 3-month assessment from induction BCG\n    * \"Adequate\" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either\n\n      * ≥ 2 of 3 doses of maintenance BCG, or\n      * ≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period\n* More than one prior induction course of BCG and\u002For prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease\n* Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200)\n* Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed)\n* Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies\n* Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies\n* Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 120 days prior to randomization.\n\n  \\* The radiographic imaging includes a CT Scan or MRI of the abdomen\u002Fpelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen\u002Fpelvis without intravenous contrast is acceptable\n* Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease\n* Patients with a history of, or current evidence of, non-invasive (Ta\u002FTis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age ≥ 18 years\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Not pregnant and not nursing, Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\n\n  * has achieved menarche at some point\n  * has not undergone a hysterectomy or bilateral oophorectomy\n  * has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)","ALL","18 Years",{"count":20,"type":21},330,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.",[27,28,29],"Recurrent Non-Muscle Invasive Bladder Carcinoma","Stage 0a Bladder Cancer AJCC v8","Stage I Bladder Cancer AJCC v8","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2025-07-17",{"date":38,"type":21},"2028-12-05",{"name":40,"class":41},"Alliance for Clinical Trials in Oncology","OTHER",58,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100572445","phase-2-a-cruciferous-vegetable-eating-program-for-the-reduction-of-cancer-recurrence-and-progression-in-patients-with-non-muscle-invasive-bladder-cancer-100572445","NCT06733363","A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer","A Scalable Cruciferous Vegetable Intervention to Reduce Bladder Cancer Recurrence and Progression","Inclusion Criteria:\n\n* English speaking\n\n  * Diagnosed with stage Tis, Ta, or T1 bladder cancer\n  * Age 18 years old or older (no upper limit)\n  * Resides in New York State\n  * Cancer not reported by a lab, nursing home, or death certificate\u002Fautopsy only\n  * Did not receive a partial or radical cystectomy\n  * Does not have other cancer diagnosis within 12 month of bladder cancer diagnosis except for cancers deemed low risk and unlikely to impact study participation (e.g., basal cell carcinoma, nor under active treatment for any other cancers\n\nExclusion Criteria:\n\n* Participants who had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n\n  * Adults unable to consent\n  * Adults unable to complete study measures in English\n  * Individuals who are not yet adults (infants, children, teenagers)\n  * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Unwilling or unable to follow protocol requirements\n  * The following special populations ae excluded from this study:\n\n    * Cognitively impaired adults\u002Fadults with impaired decision-making capacity\n    * Individuals who are not yet adults (infants, children, teenagers)\n    * Pregnant women\n    * Prisoners",{"count":51,"type":21},344,[53],"PHASE2","This phase II trial is being done to develop and test a healthy eating program to reduce cancer recurrence (cancer that has come back after a period of improvement) and\u002For progression (cancer that is growing, spreading, or getting worse) in patients with non-muscle invasive bladder cancer (NMIBC). Researchers want to better understand how incorporating more cruciferous vegetables in the diet may reduce the risk of cancer recurrence or progression in men and women who were diagnosed with early-stage bladder cancer and compare whether extending the program can further improve bladder cancer outcomes. POW-R Health is a behavioral dietary intervention designed to modestly increase cruciferous vegetable (cruciferae) intake in patients. Cruciferous vegetables, such as cabbage, kale and broccoli, arugula, contain phytochemicals known as isothiocyanates (ITCs). Dietary ITCs exert potent anticancer activities against bladder cancer and can be rapidly metabolized, delivered to the bladder, and concentrated in the urine. Participating in the healthy eating program may reduce bladder cancer recurrence or progression in NMIBC survivors.",[56,57,27,28,58],"Non-Muscle Invasive Bladder Carcinoma","Recurrent Bladder Carcinoma","Stage 1 Bladder Cancer AJCC v8","2026-05-07",{"date":61,"type":34},"2026-05-08",{"date":63,"type":34},"2026-01-13",{"date":65,"type":21},"2029-02-28",{"name":67,"class":41},"Roswell Park Cancer Institute",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":68},"100529405","phase-1-plz4-coated-paclitaxel-loaded-micelles-for-the-treatment-of-patients-with-recurrent-or-refractory-non-muscle-invasive-bladder-cancer-100529405","NCT06173349","PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer","A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer","Inclusion Criteria:\n\n* Histologically confirmed non muscle invasive bladder cancer (NMIBC), defined as noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or carcinoma invading the subepithelial connective tissue (T1), determined via transurethral resection of bladder tumor (TURBT) within 3 months of enrollment\n* Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG. BCG-unresponsive disease is defined as being at least one of the following:\n\n  * Persistent or recurrent CIS alone or with recurrent Ta\u002FT1 (noninvasive papillary disease\u002Ftumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy\n  * Recurrent high-grade Ta\u002FT1 disease within 12 months of completion of adequate BCG therapy\n  * T1 high-grade disease at the first evaluation following an induction BCG course. In this context, adequate BCG therapy is defined as at least one of the following:\n\n    * At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy\n    * At least five of six doses of an initial induction course plus at least two of six doses of a second induction course\n* Refuse or intolerant of a radical cystectomy recommended by the treating urologist as the standard next therapy per American Urological Association (AUA) guideline\n* Age ≥ 18 years at time of consent\n* Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Patient with life expectancy greater than 24 months\n* No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks\n* No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation\n* Recovery from prior treatment side effects that might interfere with the study treatment, in the judgment of the investigator\n* Absolute neutrophil count (absolute granulocyte count \\[AGC\\]\u002Fabsolute neutrophil count \\[ANC\\]) ≥ 1,500\u002FµL\n* Platelets ≥ 100,000\u002FµL (Patients may be transfused to meet this requirement)\n* Hemoglobin ≥ 8 g\u002FdL (Patients may be transfused to meet this requirement)\n* Calculated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (\\\u003C 3 × ULN for patients with Gilbert's syndrome)\n* Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 3.0 × institutional ULN\n* Adequate pulmonary function by clinical assessment with no clinical signs of severe pulmonary dysfunction\n* Participants of childbearing potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 3 months after last study treatment; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy)\n* Ability to understand and willingness to sign an informed consent form\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Existence of cancer at the upper urinary tract\n* Concurrent use of other investigational agents\n* Evidence of regional and\u002For distant metastasis\n* NYHA (New York Heart Association) class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction\n* Symptomatic congestive heart failure (CHF), severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry\n* Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease)\n* Patient taking medications that affect coagulation, such as aspirin (though, aspirin 81 mg oral once daily is allowed), Coumadin\u002FWarfarin, heparin, low molecular weight heparin, direct thrombin inhibitors, and direct factor Xa inhibitors. Other nonsteroidal antiinflammatory drugs (NSAIDs) are allowed as long as they are discontinued the day before therapy\n* History or evidence of uncontrollable central nervous system (CNS) disease\n* Active systemic infection requiring parenteral antibiotic therapy\n* Women who are pregnant or breast feeding\n* Any other malignancy diagnosed within 3 years of trial entry with the exception of the following:\n\n  * Basal or squamous cell skin cancers, or\n  * Noninvasive cancer of the cervix, or\n  * Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period, such as localized prostate cancer after definitive treatment and prostate-specific antigen (PSA) less than 0.2 ng\u002FmL\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial",{"count":77,"type":21},12,[79],"PHASE1","This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a bladder cancer-specific nanoparticle that can specifically target and deliver treatment to the tumor cells in the bladder. PPM contains paclitaxel, which is a drug that kills tumor cells or keeps them from growing.",[27,28,82,29],"Stage 0is Bladder Cancer AJCC v8","2026-03-11",{"date":85,"type":34},"2026-03-13",{"date":87,"type":34},"2023-11-22",{"date":89,"type":21},"2027-06",{"name":91,"class":41},"University of California, Davis"]