RECRUITING

PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

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Conditions

Recurrent Non-Muscle Invasive Bladder CarcinomaStage 0a Bladder Cancer AJCC v8Stage 0is Bladder Cancer AJCC v8Stage I Bladder Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer

Quick Facts

Study Start:2023-11-22
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06173349

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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:
  3. * 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
  4. * Recurrent high-grade Ta/T1 disease within 12 months of completion of adequate BCG therapy
  5. * 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:
  6. * At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
  7. * At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
  8. * Refuse or intolerant of a radical cystectomy recommended by the treating urologist as the standard next therapy per American Urological Association (AUA) guideline
  9. * Age ≥ 18 years at time of consent
  10. * Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  11. * Patient with life expectancy greater than 24 months
  12. * No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks
  13. * No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation
  14. * Recovery from prior treatment side effects that might interfere with the study treatment, in the judgment of the investigator
  15. * Absolute neutrophil count (absolute granulocyte count \[AGC\]/absolute neutrophil count \[ANC\]) ≥ 1,500/µL
  16. * Platelets ≥ 100,000/µL (Patients may be transfused to meet this requirement)
  17. * Hemoglobin ≥ 8 g/dL (Patients may be transfused to meet this requirement)
  18. * Calculated glomerular filtration rate (GFR) ≥ 30 mL/min
  19. * Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (\< 3 × ULN for patients with Gilbert's syndrome)
  20. * Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 3.0 × institutional ULN
  21. * Adequate pulmonary function by clinical assessment with no clinical signs of severe pulmonary dysfunction
  22. * 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)
  23. * Ability to understand and willingness to sign an informed consent form
  24. * Ability and willingness to adhere to the study visit schedule and other protocol requirements
  1. * Existence of cancer at the upper urinary tract
  2. * Concurrent use of other investigational agents
  3. * Evidence of regional and/or distant metastasis
  4. * 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
  5. * Symptomatic congestive heart failure (CHF), severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry
  6. * Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease)
  7. * 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
  8. * History or evidence of uncontrollable central nervous system (CNS) disease
  9. * Active systemic infection requiring parenteral antibiotic therapy
  10. * Women who are pregnant or breast feeding
  11. * Any other malignancy diagnosed within 3 years of trial entry with the exception of the following:
  12. * Basal or squamous cell skin cancers, or
  13. * Noninvasive cancer of the cervix, or
  14. * 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
  15. * Any condition that would prohibit the understanding or rendering of informed consent
  16. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Contacts and Locations

Principal Investigator

Mamta Parikh
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: Mamta Parikh

  • Mamta Parikh, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-22
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-11-22
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Non-Muscle Invasive Bladder Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8