Is NCT05519241 recruiting in Boston, MA?

Yes, NCT05519241 is currently recruiting participants at its Boston, MA location. This non-muscle-invasive bladder cancer clinical trial is actively enrolling qualified participants.

How do I join the non-muscle-invasive bladder cancer clinical trial in Boston?

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

Is participation in this Boston 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.

Non-muscle-invasive Bladder Cancer Clinical Trial in Boston, MA

About This Non-muscle-invasive Bladder Cancer Study in Boston

This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill bladder cancer cells. In this trial, PPM will be instilled into the bladder cavity to treat bladder cancer that does not invade into the muscle layer of the bladder and that has failed the treatment of another drug BCG. Up to 29 patients will be enrolled into the trial. The main goal of this trial is to determine the dose of PPM for future clinical trials, assess the toxicity and obtain preliminary data regarding its effectiveness.

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

Patients must meet all of the following criteria to be eligible for study entry.

Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer. Patients are eligible if the biopsy was done within 3 months of enrollment and a cystoscopy demonstrates no gross disease invasion into muscularis propria within 4 weeks of enrollment.

Patient must have BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG. Treatment of pembrolizumab is not an inclusion or

Exclusion Criteria

as intravesical taxane probably has comparable efficacy as intravenous pembrolizumab. BCG-unresponsive disease is defined as being at least one of the following:

Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy

Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy

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:

At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy

At least five of six doses of an initial induction course plus at least two of six doses of a second induction course

Refuse or intolerant of a radical cystectomy recommended by the treating urologist as the standard next therapy per urologic guidelines.

Age 18 years.

Performance status: ECOG performance status of 0, 1, or 2 (Appendix A) or Karnofsky performance status of 50 or higher (Appendix B).

Patient with life expectancy greater than 24 months.

No concurrent radiotherapy, chemotherapy, or other immunotherapy

No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation.

Recovery from prior treatment side effects that might interfere with the study treatment, in the judgment of the participating urologist.

Laboratory tests performed within 14 days of study enrollment:

Absolute neutrophil count (AGC/ANC) 1,500/uL

Platelets 100,000/uL \[Patients may be transfused to meet this requirement\]

Hemoglobin 8 g/dL \[Patients may be transfused to meet this requirement\]

Calculated glomerular filtration rate (GFR) 50 mL/min/1.73m2

Total bilirubin 2.0 X ULN (\< 3 x ULN for patients with Gilbert's syndrome)

AST, ALT, ALP 3.0 X ULN

Adequate pulmonary function with no clinical signs of severe pulmonary dysfunction.

Negative serum pregnancy test if the study participant is a female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).

Female participants of childbearing potential must adhere to using a medically accepted method of birth control, i.e. a tubal ligation, an approved hormonal contraceptive or an intrauterine device, prior to screening and agree to continue its use during the study and up to 3 months after finishing this study or be surgically sterilized (e.g., hysterectomy or tubal ligation). Males must agree to use barrier methods of birth control while on study.

Provide signed informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry.

Existence of cancer at the upper urinary tract

Concurrent use of other investigational agents.

Evidence of regional and/or distant metastasis.

NYHA (New York Heart Association) Class III or IV heart failure (Appendix C), uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction.

Symptomatic congestive heart failure (CHF), severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.

Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease).

Patient taking medications that affect coagulation, such as aspirin (aspirin 81 mg oral once daily is allowed), Coumadin/Warfarin, heparin, low molecular weight heparin, direct thrombin inhibitors, and direct factor Xa inhibitors. Other nonsteroidal anti-inflammatory drugs (NSAIDs) are allowed as long as they are discontinued the day before therapy.

History or evidence of uncontrollable central nervous system (CNS) disease.

Active systemic infection requiring parenteral antibiotic therapy.

Women who are pregnant or nursing.

Psychiatric illness/social situations that would limit compliance with study requirements

Other illness that in the opinion of the investigator would exclude the patient from participating in this study.

Any other malignancy diagnosed within 3 years of trial entry with the exception of:

Basal or squamous cell skin cancers, or

Noninvasive cancer of the cervix, or

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/ml.

Patients unwilling to or unable to comply with the protocol.

Patients with impaired decision-making capacity.

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 Boston?

Yes, this clinical trial (NCT05519241) has an active research site in Boston, MA 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.

Non-muscle-invasive Bladder Cancer Treatment Options in Boston, MA

If you're searching for non-muscle-invasive bladder cancer treatment options in Boston, MA, this clinical trial (NCT05519241) 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 Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-muscle-invasive bladder cancer 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 non-muscle-invasive bladder cancer clinical trials near you to find additional studies recruiting in your area.

Non-muscle-invasive Bladder Cancer Clinical Trial in Boston, MA

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