Clinical trial for Non-muscle-invasive Bladder Cancer
Official title A Phase I Intravesical PPM Therapy for NMIBC
ClinicalTrials.gov ID: NCT05519241
What this study is testing
What is PLZ4-coated paclitaxel-loaded micelles (PPM)?
an investigational intravesical medicine being studied as a potential treatment for non‑muscle‑invasive bladder cancer that has not responded to BCG. is designed to deliver the chemotherapy drug paclitaxel directly to bladder cancer cells using tiny micelle particles coated with a targeting molecule (PLZ4).
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 study is testing whether PPM is safe and works in people with non‑muscle‑invasive bladder cancer who did not respond to BCG.
- Who it's for
- You may be able to join if you have non‑muscle‑invasive bladder cancer that did not improve after BCG treatment.
- What's involved
- You would receive PPM, a tiny particle that carries chemotherapy, placed into your bladder. You will have clinic visits for checks and tests.
- Time commitment
- The study lasts a few months with several visits, including the treatment and follow‑up checks.
- 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 bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer.
- Patient must have BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG.
You likely can't join if
- 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 6 months of completion of adequate BCG therapy
- 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
- Performance status: ECOG performance status of 0, 1, or 2 or Karnofsky performance status of 50 or higher
See the full eligibility criteria
- Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer.
- 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
- 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
- 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
- Performance status: ECOG performance status of 0, 1, or 2 or Karnofsky performance status of 50 or higher
- 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
- Absolute neutrophil count (AGC/ANC)1,500/uL
- Platelets100,000/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.
- 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...
- 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 (aspirin 81 mg oral once daily is allowed), Coumadin/Warfarin, heparin, low molecular weight heparin, direct thrombin inhibitors, and direct factor Xa...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.