Patients must have histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration; the carcinoma must be stage T1 high-grade, stage CIS, or stage Ta high-grade
Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype
Evidence of muscle-invasive or regional and/or distant metastatic bladder cancer, or high grade urothelial carcinoma in the prostate or upper urinary tract
Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atricurium, cisatricurium, etc.)
Diagnosis of muscle-invasive bladder cancer
Pathologically demonstrated BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component, any T1, or Ta high-grade lesions
Participants may not have current or history of clinically significant muscle disorders (eg, myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels
Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder.
History of muscle cramps or restless legs
Patients must have histologically or cytologically confirmed by National Cancer Institute (NCI) Laboratory of Pathology as high grade non-muscle invasive urothelial (transitional cell carcinoma) of the bladder as follows:\r\n* Carcinoma-in-situ (CIS) with or without papillary tumors\r\n* High-grade Ta or T1 disease based on a biopsy/Transurethral Resection of Bladder Tumor (TURBT) performed within 12 weeks of the initial dose of study treatment; if multiple bladder biopsies/TURBTs are required to confirm eligibility, the timing of the last bladder biopsy to the initial dose of study treatment must be within 12 weeks\r\n* Patients with persistent T1 high grade disease on TURBT following a single induction course of BCG (at least 5 of 6 doses) may also be eligible for this trial provided that the patient is surgically unfit for cystectomy as deemed by the investigator or the patient declines cystectomy
Patient must have a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer according to the 2016 American Urological Association (AUA) Guidelines, except for strongly-suspected PUNLMP.
Bladder cancer that was muscle invasive or positive for lymph node or distant metastasis
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Patients with high risk muscle invasive urothelial carcinoma (hydronephrosis, palpable mass on examination under anesthesia, muscle invasive urothelial carcinoma with lymphovascular invasion on pathologic specimen, > T3 disease) or those with lymph node positive or metastatic disease are to be excluded
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Cohort A – T2, Transitional cell carcinoma (TCC) muscle invasive bladder cancer, (patients who are cisplatin ineligible, decline neoadjuvant and/or ineligible for neoadjuvant chemotherapy); must have histological proof of T2, muscle-invasive transitional cell carcinoma of the bladder with no evidence of metastatic; patient with any degree of fixation of the pelvic sidewall are not eligible
Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
Have muscle-invasive (>= T2) bladder cancer
Recurrent high-risk non-muscle-invasive bladder cancer after prior intravesical BCG therapy meeting all of the following criteria: \r\n* Histologically documented diagnosis of urothelial carcinoma confirmed by the Department of Pathology at Memorial Sloan Kettering Cancer Center (MSKCC)\r\n* Documentation of activating FGFR3 mutation or gene fusion on an assay performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\r\n* History of high-grade non-muscle-invasive bladder cancer (NMIBC)\r\n* Clinical evidence of high-grade, stage pTa NMIBC\r\n* Prior intravesical therapy with at least one induction course of BCG\r\n* Multiple papillary lesions with at least one amenable to marker tumor study (=< 1 cm, non-invasive; or could be partially resected to leave a non-invasive lesion =< 1 cm) OR solitary papillary lesion amenable to marker tumor study (=< 1 cm, non-invasive)
History of another malignancy within 5 years prior to randomization except for non-melanomatous carcinoma of the skin or adequately treated, non-muscle-invasive, urothelial carcinoma of the bladder (i.e., TIS, Ta and low-grade T1 tumors)
Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV)
History of another malignancy within 5 years prior to randomisation except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours).
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Histological proof of muscle-invasive urothelial carcinoma of the bladder (stage cT2-cT3b, N0-1, M0). Subjects with mixed histology are required to have documented dominant transitional cell pattern with no more than 10% squamous differentiation and 10% glandular differentiation. Micropapillary/sarcomatoid/adenocarcinoma/plasmacytoid variants are not allowed.
Localized, muscle invasive urothelial carcinoma (T2-4, N0-1, M0) (mixed histology acceptable) ineligible for cystectomy
Non-muscle invasive, localized bladder cancer (Tis, Ta, T1)
Prior systemic chemotherapy for bladder cancer; prior intravesical chemotherapy for the treatment of non-muscle invasive urothelial bladder cancer (UBC) is allowed
Diagnosis of presumed non-muscle invasive bladder cancer based on office based cystoscopy (primary or recurrent), and planned transurethral resection of bladder tumor (TURBT)
Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels
Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows:
Patients must have pathologically confirmed non-muscle invasive bladder cancer (NMIBC) high grade disease (HG), as defined by the 2004 WHO classification system
Patients must have no evidence of muscle invasive disease
T1 patients need to have evidence of muscle included in their latest biopsy; and if not a re-TURBT has to be done prior to enrollment
Muscle invasive urothelial carcinoma of the bladder histologically confirmed at the enrolling institution; (urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed provided the extent of disease is confirmed via imaging and/or EUA)
History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours).
Patients must have a histologically confirmed diagnosis of non- muscle invasive urothelial carcinoma of the bladder at the study institution prior to the beginning of the study; this includes patients with:\r\n* High grade Ta papillary lesion(s)\r\n* High or low grade T1 papillary lesion(s) \r\n* Carcinoma in situ (CIS), with or without Ta or T1 papillary tumor(s) of any grade
Histologically or cytologically confirmed non-muscle invasive bladder cancer [Ta, T1 or Tis (CIS)] that has been removed by transurethral resection
Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence of non-muscle invasive bladder cancer
Muscle invasive urothelial carcinoma of the bladder histologically confirmed at Memorial Sloan Kettering Cancer Center (MSKCC) or participating site; (urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or endoscopic ultrasonic aspiration [EUA])
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Initial histological diagnosis of muscle invasive urothelial carcinoma
Previous muscle-invasive (i.e., stage T2 or higher) transitional-cell carcinoma of the bladder
Histologically confirmed muscle invasive transitional cell carcinoma of the bladder at Memorial Sloan-Kettering Cancer Center (MSKCC); (Note: urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or exam under anesthesia [EUA])
Histologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder with carcinoma in-situ (CIS)
Evidence of locally advanced, metastatic, muscle-invasive, and/or extravesical bladder cancer
Have a history of muscle invasive bladder cancer
Any subjects with muscle-invasive TCC (stages T2 - T4) OR any known TCC of the ureter or renal pelvis are not allowed
Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell carcinoma on pre-operative histology (i.e. biopsy or transurethral resection of bladder tumor [TURBT]).
Patients only: must have a tumor in extremity muscle tissue or in the pelvis
Evidence of accessory respiratory muscle use with breathing
Patients who present to the urology clinic for non-muscle-invasive bladder cancer will be screened for participation in this pilot study (goal of 5 patients); patients who have completed transurethral resection of bladder tumor (TURBT) and are candidates for intravesical therapy are eligible for inclusion
Patients with evidence of muscle-invasion or metastatic disease will be excluded
Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of fixation of the pelvic sidewall are not eligible.
The subject is undergoing one of the following reconstructive procedures that requires latissimus dorsi muscle harvest: a. post-mastectomy breast reconstruction procedure (either nipple or skin sparing) in which a female subject needs additional muscle coverage over an implant, but does not need additional skin (i.e., patient is a candidate for a pedicled latissimus dorsi muscle flap procedure); b. scalp reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; c. upper extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; or, d. lower extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage
At least one muscle spasm per day at time of screening
Muscle spasms onset after starting vismodegib
Presence of muscle spasms or active neurologic disease prior to start of vismodegib
Use of muscle relaxant medications such as cyclobenzaprine within four weeks of enrollment and during course of the study, unless the regimen of muscle relaxants is stable for 4 weeks prior to enrollment and does not change for the duration of the study
Male and female patients who present to the urology clinic for recurrent non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) and are candidates for radical cystectomy will be screened for participation
Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, Ta high grade [HG], or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumors
Patients found to require sternocleidomastoid muscle or internal jugular vein excision
Patients with a prior diagnosis of non-muscle invasive, ?T1, urothelial cell\n             carcinoma of the bladder scheduled to undergo surveillance cystoscopy.
Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2\n             or greater)
Histologically confirmed muscle-invasive urothelial cancer of the bladder within 60 days of study enrollment\r\n* Patients must be willing to provide a TURBT specimen during screening and prior to enrollment if adequate specimen (formalin-fixed paraffin-embedded [FFPE] tissue block or 20 unstained slides) from initial TURBT documenting muscle-invasive urothelial bladder cancer is not available