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New treatment option for Recurrent Non-Muscle Invasive Bladder Carcinoma
Official title PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06173349
What this study is testing
What is PLZ4-coated paclitaxel loaded micelles (PPM)?
PLZ4-coated paclitaxel loaded micelles (PPM) is an investigational medicine, given as an once-weekly, being studied as a potential treatment for recurrent non-muscle invasive bladder carcinoma.
Also referred to as Paclitaxel, PPM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed non muscle invasive bladder cancer (NMIBC), defined as noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or...
- Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG. BCG-unresponsive disease is defined as...
- Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease...
- 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...
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.