ChemotherapySystemicAdjuvantBladder cancerMitomycinTransurethral resectionImmunotherapyVaccineIntraperitonealUrinary BladderBacillusValrubicinRoute of administratCatheterDetrusorNadofarageneToxicityEfficacyTURBTTumorsGene therapyTumorUrethralResectionRecurrenceInjectionTherapyInjectionsInfusionTreatmentDurationContrastDrugDeliveryPatientsOralEffectiveHoursSingle
Chemotherapy11
- In a patient with suspected or known low- or intermediate-risk bladder cancer, a clinician should consider administration of a single postoperative instillation of intravesical chemotherapy (eg, gemcitabine, mitomycin C) within 24 hours of a transurethral resection for bladder tumor (TURBT). (medscape.com)
- This is a Phase 1 study designed to test the tolerability and feasibility of intravesical therapy with an attenuated Measles virus (MV-NIS) in patients with urothelial carcinoma who are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant chemotherapy. (bcan.org)
- Study VYR-MV1-102 is a Phase 1 study designed to determine the tolerability, feasibility and preliminary efficacy of attenuated MV-NIS virus after neoadjuvant intravesical administration prior to RC in patients with UC who are ineligible for current neoadjuvant chemotherapy. (bcan.org)
- Between December 2006 and December 2014, 53 patients with NMIBC who underwent TUR were randomly assigned to receive BHPC (BHPC group, 28 patients) or intravesical chemotherapy alone (chemotherapy group, 25 patients) at the Intracelom Hyperthermic Perfusion Therapy Center of Guangzhou Medical University Cancer Hospital (Guangzhou, China). (spandidos-publications.com)
- Although, the recurrence rate of NMIBC is significantly decreased by TUR in combination with intravesical chemotherapy, the rate of cancer progression is not diminished ( 7 - 12 ). (spandidos-publications.com)
- Intravesical chemotherapy can be used both as a single, immediate postoperative instillation, and as adjuvant chemotherapy. (uk.com)
- Meta-analysis of randomised controlled trials has shown that instillation of intravesical chemotherapy immediately following TURBT prolongs the recurrence free interval by 38% compared to both no treatment and placebo [5]. (uk.com)
- Although there has been no consensus on the optimal duration of adjuvant intravesical chemotherapy, it is not recommended beyond one year [3]. (uk.com)
- Systemic ACT-treated mice were given T cells intravenously after lymphodepleting chemotherapy and followed by interleukin (IL)-2 administration. (bmj.com)
- Intravesical ACT treated mice were given T cells directly into the bladder, without chemotherapy or IL-2. (bmj.com)
- Further intravesical chemotherapy and repeat TURB. (urology-textbook.com)
Systemic4
- Currently, intravesical administration of BCG is delayed four to six weeks after TURBT to reduce the likelihood of systemic BCG absorption and BCG sepsis. (bcan.org)
- MV-NIS has been proven safe at a dose of 1x1011 TCID50 intravenously in patients lacking MV immunity (Russell 2014), which allays concern for systemic toxicity after intravesical administration even if post-TURBT administration results in systemic MV-NIS absorption. (bcan.org)
- Final results from a pivotal clinical trial show that the investigational agent N-803 combined with bacillus Calmette-Guérin (BCG) is safe and more effective than other intravesical and systemic options for high-risk nonmuscle-invasive bladder cancer (NMIBC) that is unresponsive to BCG alone, according to an oral presentation at the 2022 ASCO Annual Meeting. (renalandurologynews.com)
- Delivery through a catheter, called intravesical administration, limits systemic exposure to both the viral vectors and to inteferon, said Neal Shore, m edical director for the Carolina Urologic Research Center and an investigator in the trial. (biopharmadive.com)
Adjuvant4
- 2 3 Per clinical guidelines, intermediate-risk and high-risk NMIBC are initially treated locally with transurethral resection (TURBT) followed by therapeutic or adjuvant intravesical BCG. (bmj.com)
- The adjuvant intravesical therapy is possible with mitomycin C or BCG, depending on the risk profile according to the table simple risk stratification . (urology-textbook.com)
- Multiple, large, and recurrent tumours (those that have come back) may benefit from adjuvant treatment with intravesical Mitomycin or Epirubicin. (ivo.es)
- The IVO works with a strict intravesical adjuvant protocol that, in addition to standard treatments, also includes innovative instillation systems such as hyperthermia and electromotive drug administration (EMDA), which improve the administration of these drugs. (ivo.es)
Bladder cancer8
- Parsippany, NJ - September 12, 2023 - Ferring Pharmaceuticals today announced the first patient in the United States with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) was dosed with the commercially available intravesical gene therapy ADSTILADRIN ® (nadofaragene firadenovec-vncg) as part of the ADSTILADRIN Early Experience Program announced earlier this year . (ferringusa.com)
- Bladder cancer: where are we with intravesical therapies? (uk.com)
- Seventy percent of new cases will be non-muscle invasive bladder cancer (NMIBC) at diagnosis and therefore will be managed in a bladder sparing manner with transurethral resection (TURBT), with or without intravesical therapy . (uk.com)
- This intravesical administration is quite favorable, and quite familiar amongst those who normally treat patients with BCG-unresponsive bladder cancer. (onclive.com)
- The milestone payment is contingent on certain manufacturing goals that are expected to be achieved in 2025 for the FDA-approved intravesical gene therapy that Ferring will make available next month through an early experience program for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. (ferring.in)
- A separate study arm evaluated a post-TURBT single IMI/IVT administration of NanoDoce for safety over a 45-day period in 17 patients with muscle invasive bladder cancer. (crititech.com)
- 10 ] Bacille Calmette-Guerin (BCG) vaccine is a live, attenuated form of M. bovis commonly utilized in the United States for its unique utility in the treatment of bladder cancer through intravesical administration. (surgicalneurologyint.com)
- 7 ] We found 25 reports of spinal TB related to intravesical administration of BCG vaccine for the treatment bladder cancer. (surgicalneurologyint.com)
Mitomycin5
- Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. (nih.gov)
- In humans, mitomycin is rapidly cleared from the serum after intravenous administration. (nih.gov)
- The UK has been experiencing a shortage of mitomycin 2mg, 10mg, 20mg vials for intravenous administration and 40mg for intravesical administration since late October 2019. (rcophth.ac.uk)
- Early single-shot intravesical instillation of mitomycin C after TURB reduces the recurrence rate by 40% (Sylvester et al. (urology-textbook.com)
- 2004). Dosage: 40 mg intravesical mitomycin C, exposure time 1-2 hours (no irrigation or gravity drainage). (urology-textbook.com)
Transurethral resection2
- Delay administration at least two weeks after transurethral resection and/or fulguration. (drugs.com)
- We determined if a third of the dose of intravesical bacillus Calmette-Guerin (BCG) has the same efficacy than a standard dose for decreasing the risk of recurrence and progression after transurethral resection in patients with superficial high risk (stages T1G3 and carcinoma in situ) bladder cancer. (nih.gov)
Immunotherapy1
- High-grade tumours are treated with intravesical immunotherapy (BCG) to reduce the risk of recurrence and progression. (ivo.es)
Vaccine1
- The vaccine is administered by intraperitoneal, intratumoral, intravesical and intravenous and intrapleural routes of administration. (pharmaceutical-technology.com)
Intraperitoneal1
- Notably, intraperitoneal administration of imperatorin had no discernible effect on urinary bladder function and micturition cycles in normal rats. (bvsalud.org)
Urinary Bladder1
- Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. (drugs.com)
Bacillus1
- ADSTILADRIN was approved by the U.S. Food & Drug Administration (FDA) in December 2022 for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. (ferringusa.com)
Valrubicin11
- These highlights do not include all the information needed to use VALRUBICIN INTRAVESICAL SOLUTION safely and effectively. (drugs.com)
- See full prescribing information for VALRUBICIN INTRAVESICAL SOLUTION. (drugs.com)
- Valrubicin intravesical solution is recommended at a dose of 800 mg administered intravesically once a week for six weeks. (drugs.com)
- Warm valrubicin intravesical solution slowly to room temperature, but do not heat. (drugs.com)
- Use caution when handling and preparing the solution of valrubicin intravesical solution. (drugs.com)
- Evaluate the status of the bladder before the intravesical instillation of valrubicin intravesical solution. (drugs.com)
- Embryo-Fetal Toxicity: Valrubicin intravesical solution can cause fetal harm. (drugs.com)
- Handle and dispose of valrubicin intravesical solution in a manner consistent with other cytotoxic drugs. (drugs.com)
- Valrubicin intravesical solution contains polyoxyl castor oil, which has been known to cause leaching of di(2-ethylhexyl) phthalate (DEHP) a hepatotoxic plasticizer, from polyvinyl chloride (PVC) bags and intravenous tubing. (drugs.com)
- Valrubicin intravesical solution should be prepared and stored in glass, polypropylene, or polyolefin containers and tubing. (drugs.com)
- Valrubicin intravesical solution is a clear red solution. (drugs.com)
Route of administrat2
- The Prostate Cancer pipeline drugs market research report provides comprehensive information on the therapeutics under development for Prostate Cancer, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA), and molecule type. (globaldata.com)
- Further, therapies designed for intravenous route of administration are expected to occupy close to 70% of the overall market. (digitalshivamsharma.com)
Catheter1
- Ultrasonography of the urinary tract: 1mL via intravesical bolus inj through the urinary catheter. (empr.com)
Detrusor1
Nadofaragene1
- Aside from the remission rates, Shore said nadofaragene firadenovec would differentiate itself from Keytruda in practice because its intravesical delivery means it could be administered by community-based urologists at outpatient clinics. (biopharmadive.com)
Toxicity1
- Our results suggest that a 3-fold decreased dose of intravesical BCG is as effective as the standard dose against progression in patients with high risk stages T1G3 and Tis superficial bladder carcinoma but with significantly less toxicity. (nih.gov)
Efficacy1
TURBT3
- Investigators will use a novel adaptive trial design that varies the time between TURBT, virus administration and RC. (bcan.org)
- Given this clinical safety precedent, Investigators propose initial patients be treated within one week of RC to maximize the time between TURBT and MV-NIS administration. (bcan.org)
- Subsequent patients will be treated earlier before RC (up to 29 days prior), thereby reducing the interval between TURBT and virus administration to maximize the treatment duration before RC. (bcan.org)
Tumors1
- Intravesical delivery of TIL expanded from MB49 tumors was also able to decrease tumor growth in mice with MB49 orthotopic tumors. (bmj.com)
Gene therapy2
- It is the first and only FDA-approved intravesical gene therapy for adults with NMIBC who no longer respond to standard therapy. (ferringusa.com)
- Making this novel and efficacious intravesical gene therapy commercially available for patients underscores our commitment to changing the trajectory of NMIBC. (ferringusa.com)
Tumor3
- Numerous clinical trials have shown that combining MMC administration with hypothermia can improve tumor ablation and prevent recurrence post-TUR. (spandidos-publications.com)
- Blocking CXCR3 on OT-I T cells prior to intravesical delivery decreased T cell infiltration into the tumor and prevented the control of tumor growth. (bmj.com)
- The aim of resection is the complete removal of the tumor manifestation, for this purpose the tumor is either resected in fractions (standard method) or dissected en bloc with tumor base from the bladder wall. (urology-textbook.com)
Urethral1
- In an intermediate- or high-risk patient with persistent or recurrent disease or positive cytology following intravesical therapy, consider performing prostatic urethral biopsy and an upper tract evaluation prior to administering additional intravesical therapy (conditional recommendation, evidence strength, grade C). (medscape.com)
Resection2
- If a R0 resection is achieved, continue with intravesical therapy and close follow-up with repeat biopsies. (urology-textbook.com)
- En-bloc resection is done with a monopolar hook, the resection loop, or the laser technique. (urology-textbook.com)
Recurrence2
- Use of intravesical therapy is guided by risk of progression and recurrence of individual tumours. (uk.com)
- Intravesical therapy can safely reduce the risk of recurrence and progression of superficial bladder carcinomas. (urology-textbook.com)
Injection2
- The logical second‐line treatment is the intravesical injection of botulinum toxin A, considering its temporary effectiveness and the possibility of retention. (intechopen.com)
- L'agrégation plaquettaire induite par le collagène dans des échantillons de plasma riche en plaquettes de 14 lapins sains a été mesurée par turbidimétrie en utilisant un agrégomètre, avant et une heure après une injection intra- veineuse d'alun. (who.int)
Therapy2
- Despite advances in all areas of medicine, the use of intravesical therapy is inconsistent worldwide and advances have been adopted slowly. (uk.com)
- Intravesical maintenance therapy. (urology-textbook.com)
Injections2
- Mouse bladder afferents of P2X 3 +/+ , but not P2X 3 − /− , were rapidly activated by intravesical injections of P2X agonists (ATP or α,β-methylene ATP) and subsequently showed an augmented response to bladder distension. (jneurosci.org)
- Background: The human resources for health crisis in rural Eswatini led to a novel community-based multidrug-resistant tuberculosis (MDR-TB) treatment strategy based on task-shifting, that is delegation of directly observed treatment (DOT) and administration of MDR-TB injections, traditionally restricted to professional nurses, to lay community treatment supporters (CTSs). (bvsalud.org)
Infusion2
- Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. (medscape.com)
- Intravesical infusion of RA induced OAB. (bvsalud.org)
Treatment1
- On May 23, ImmunityBio Inc, which is developing N-803, announced that it submitted a Biologics License Application to the US Food and Drug Administration for N-803 for use with BCG as a treatment for BCG-unresponsive NMIBC CIS with or without Ta or T1 disease. (renalandurologynews.com)
Duration1
- In a phase 1b trial, administration of intravesical N-803 plus BCG in BCG-naïve patients with NMIBC induced CR without recurrences for the study duration of 24 months, according to investigators. (renalandurologynews.com)
Contrast1
- A standard imaging test has been an X-ray examination with intravesical administration of an iodine contrast agent for assessment of the excretory urinary tract. (bracco.com)
Drug5
- 1 The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug. (drugs.com)
- NanoDoce (LSAM docetaxel) suspension is composed of large surface area microparticles of pure docetaxel designed for local administration and sustained drug release over time. (crititech.com)
- 4 5 BCG was one of the first Food and Drug Administration (FDA)-approved immunotherapies to treat cancer in the 1970s, but over the past decade BCG supply has become increasingly limited due to manufacturing shortages. (bmj.com)
- The Food and Drug Administration (FDA) believes that the recommendations in this guidance document will improve the quality of postmarketing safety reports and clarify the industry's current safety reporting responsibility to assure public health. (cdc.gov)
- 1This guidance has been prepared by the Epidemiology Branch in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. (cdc.gov)
Delivery1
Patients2
- Patients were treated with 50 mg of BCG plus 400 mg of intravesical N-803 weekly for 6 weeks, followed by re-induction for re-induction and maintenance for up to 3 years. (onclive.com)
- Ces résultats semblent indiquer que l'utilisation de l'alun en tant qu'antiplaquettaire oral pourrait faire l'objet d'études complémentaires, en tenant compte des effets secondaires éventuels notamment chez les patients dont la fonction rénale est altérée. (who.int)
Oral1
- The use of oxybutynin transdermal should be considered when the side effects due to the oral administration are intolerable. (intechopen.com)
Effective1
- Local administration to the bladder can be effective without causing high concentrations in the serum, and thus, causing only mild side-effects ( 8 , 12 , 14 , 16 , 17 ). (spandidos-publications.com)
Hours1
- At 48 hours after intravesical instillation cystometric studies were performed using urethane anesthesia (0.04 ml per minute). (duke.edu)
Single1
- However, as with many antidepressants, the results of a single administration of ketamine wane with time. (wikipedia.org)