Is NCT05833867 recruiting in Cleveland, OH?

Yes, NCT05833867 is currently recruiting participants at its Cleveland, OH location. This localized muscle invasive bladder urothelial carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Cleveland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Localized Muscle Invasive Bladder Urothelial Carcinoma Clinical Trial in Cleveland, OH

Q: How do I join the localized muscle invasive bladder urothelial carcinoma clinical trial in Cleveland?

To join this clinical trial in Cleveland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Localized Muscle Invasive Bladder Urothelial Carcinoma Study in Cleveland

The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy. The main objective is to establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for participants with localized MIBC. Participants will receive the study drug, SG, through an IV once weekly on days 1 and 8 of each 21-day treatment cycle. The first cycle of SG will begin 21 days prior to the scheduled start of radiation therapy. The second and third cycles of SG will be given while the participant is receiving radiation therapy. Participants will be asked to undergo computed tomography (CT) and magnetic resonance imaging (MRI) pre-and post-treatment. Participation in the research will last up to 5 years, depending on treatment outcomes, with a treatment period of 8 weeks and a study follow-up period of up to 2-5 years thereafter, and a survival follow-up, with only phone call communication from years 3-5.

Sponsor: Shilpa Gupta, MD

Who Can Participate

Inclusion Criteria

Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed urothelial carcinoma will be eligible for the trial, except for small cell or neuroendocrine component

Participants must have received no prior systemic chemotherapy for this disease. Participants must refuse conventional radio-sensitizing chemotherapy, (and/or) must not be eligible for or refuse cystectomy while on study Participants may receive cystectomy following the end of treatment (EOT)/ Safety Visit if deemed necessary by their clinical team while still in follow-up.

Performance status: ECOG Performance status ≤ 2

Participants must have normal organ and marrow function as defined below:

Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x laboratory upper limit of normal (ULN)

Total serum bilirubin ≤ 2.0 x ULN

Absolute neutrophil count (ANC) ≥ 1500/μL

Platelets ≥ 100,000/μL

Hemoglobin ≥ 9.0 g/dL

Serum calcium ≤ 12.0 mg/dL

Calculated Creatinine Clearance ≥ 30 mL/min. Calculated using Cockcroft-Gault formula: Creatinine Clearance = \[\[140 - age(yr)\] multiplied by body weight(kg)\]/ \[72 multiplied by serum Cr(mg/dL)\] (multiply total by 0.85 for women).

Participants must have adequate baseline bladder function to warrant bladder preservation as assessed by the treating provider, including absence of bilateral hydronephrosis or acute obstruction related to bladder tumor after TURBT. Unilateral hydronephrosis is permitted.

Participants must undergo a TURBT within ≤ 60 days prior to treatment start. In a situation where a participant is referred from an outside site to the Cleveland Clinic Foundation, participant must have a repeat cystoscopy by the urologist who will be following the participant on the clinical trial to assess the adequacy of the prior TURBT. Participant may then undergo repeat TURBT if deemed necessary as standard of care by the treating urologist.

Participants may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection.

Participant must undergo radiological staging within 60 days prior to treatment start. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Participants must not have evidence of T4b and/or N1-3 dT4bN1-3 disease. Eligibility is based on review by Cleveland Clinic Foundation (CCF) radiology department and/or PI.

Participants must not have had urothelial carcinoma or any histological variant at any site outside of the urinary bladder within the previous 24 months except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract including renal, pelvis, and ureter if the participant had undergone complete nephroureterectomy.

Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants receiving or utilizing any other investigational agents or devices.

Has received prior pelvic / local radiation therapy for MIBC or any other cancer type.

Has received any prior systemic treatment, chemoradiation, and / or radiation therapy for MIBC or non-muscle-invasive bladder cancer (NMIBC). Note: Prior treatment for NMIBC with intravesical instillation therapy such as BCG or intravesical chemotherapy is permitted.

Has diagnosed Bilateral hydronephrosis.

Has limited bladder function as noted by a provider, with frequency of small amounts of urine, urinary incontinence including stress/urge, requires self-catheterization or a permanent indwelling catheter.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to SG or any of its' components.

Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or breastfeeding women are excluded from this study because SG and radiation effects during pregnancy have potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with SG, breastfeeding should be discontinued if the mother is treated with Sacituzumab Govitecan.

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Note: Participants who have entered the Follow-up Phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent.

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT05833867) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Localized Muscle Invasive Bladder Urothelial Carcinoma Treatment Options in Cleveland, OH

If you're searching for localized muscle invasive bladder urothelial carcinoma treatment options in Cleveland, OH, this clinical trial (NCT05833867) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced localized muscle invasive bladder urothelial carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all localized muscle invasive bladder urothelial carcinoma clinical trials near you to find additional studies recruiting in your area.

Localized Muscle Invasive Bladder Urothelial Carcinoma Clinical Trial in Cleveland, OH

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