Is NCT06173349 recruiting in Sacramento, CA?

Yes, NCT06173349 is currently recruiting participants at its Sacramento, CA location. This recurrent non-muscle invasive bladder carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Sacramento 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.

Recurrent Non-Muscle Invasive Bladder Carcinoma Clinical Trial in Sacramento, CA

Q: How do I join the recurrent non-muscle invasive bladder carcinoma clinical trial in Sacramento?

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

About This Recurrent Non-Muscle Invasive Bladder Carcinoma Study in Sacramento

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.

Sponsor: University of California, Davis

Who Can Participate

Inclusion Criteria

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

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:

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 12 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 American Urological Association (AUA) guideline

Age ≥ 18 years at time of consent

Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Patient with life expectancy greater than 24 months

No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks

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 investigator

Absolute neutrophil count (absolute granulocyte count \[AGC\]/absolute neutrophil count \[ANC\]) ≥ 1,500/µL

Platelets ≥ 100,000/µL (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) ≥ 30 mL/min

Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (\< 3 × ULN for patients with Gilbert's syndrome)

Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 3.0 × institutional ULN

Adequate pulmonary function by clinical assessment with no clinical signs of severe pulmonary dysfunction

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)

Ability to understand and willingness to sign an informed consent form

Ability and willingness to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

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, 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 (though, 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 antiinflammatory 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 breast feeding

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

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

Any condition that would prohibit the understanding or rendering of informed consent

Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

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 Sacramento?

Yes, this clinical trial (NCT06173349) has an active research site in Sacramento, CA 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.

Recurrent Non-Muscle Invasive Bladder Carcinoma Treatment Options in Sacramento, CA

If you're searching for recurrent non-muscle invasive bladder carcinoma treatment options in Sacramento, CA, this clinical trial (NCT06173349) 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 Sacramento research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced recurrent non-muscle invasive bladder 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 recurrent non-muscle invasive bladder carcinoma clinical trials near you to find additional studies recruiting in your area.

Recurrent Non-Muscle Invasive Bladder Carcinoma Clinical Trial in Sacramento, CA

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