Chemoablation for Low-Grade Bladder Cancer

NCT07019220 | Recruiting Phase 2 DMC

• 1 other identifier: COBRA
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Keywords

Non-Muscle Invasive Bladder Cancer; Intravesical Therapy; Non-Surgical Treatment

Outcome Measures

Primary Outcomes (1)

• Clinical complete response (cCR)

  cCR defined as negative urine cytology and absence of macroscopic tumor at the cystoscopic evaluation

  From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment).

Secondary Outcomes (3)

• Pathological complete response (pCR)

  From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment).

• Patient-reported Outcomes based on EORTC QLQ-NMIBC24

  Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).

• Patient-reported Outcomes based on EORTC QLQ-C30

  Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).

Study Arms (1)

Patients with low-grade NMIBC

EXPERIMENTAL

Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Intravesical installation

Patients with low-grade NMIBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
• Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening
• On screening cystoscopy: Diameter of the largest lesion ≤15mm
• Number of lesions ≤5
• Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
• Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
• NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
• Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
• No lymph node metastasis or distant metastasis
• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period
• Willing and able to provide informed consent

You may not qualify if:

• Tumors that clinicians suspect to be HG
• Positive HG cytology according to Paris criteria
• Diameter of tumor \>15 mm
• Number of lesions \>5
• Any previous intravesical therapy within 1 year
• Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.
• Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
• History of upper tract urothelial carcinoma (UTUC)
• Clinically significant urethral stricture that would preclude passage of a urethral catheter
• History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding
• Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
• Patient refused to participate
• Known positive human immunodeficiency virus (HIV) test.
• Female patients who are pregnant/breastfeeding.
• Female patients of childbearing potential not using adequate contraception.

Sponsors & Collaborators

• Ekaterina Laukhtina: lead

Study Sites (1)

Department of Urology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (6)

• Brausi MA, Gontero P, Altieri V, Colombo R, Conti I, Bono AV. Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study. Urol Int. 2011;87(4):470-4. doi: 10.1159/000331727. Epub 2011 Nov 11.

  PMID: 22086229 BACKGROUND

• Gardmark T, Carringer M, Beckman E, Malmstrom PU; Members of the Intravesical Gemcitabine Study Group. Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder. Urology. 2005 Sep;66(3):527-30. doi: 10.1016/j.urology.2005.03.084.

  PMID: 16140071 BACKGROUND

• Maffezzini M, Campodonico F, Canepa G, Capponi G, Fontana V. Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder. Eur Urol. 2007 Apr;51(4):956-61. doi: 10.1016/j.eururo.2006.08.038. Epub 2006 Sep 20.

  PMID: 17027141 BACKGROUND

• Campodonico F, Canepa G, Capponi G, Bozzo L, Maffezzini M. Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability. Anticancer Res. 2005 May-Jun;25(3c):2381-4.

  PMID: 16080464 BACKGROUND

• Serretta V, Galuffo A, Pavone C, Allegro R, Pavone-MacAluso M. Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions. Urology. 2005 Jan;65(1):65-9. doi: 10.1016/j.urology.2004.08.027.

  PMID: 15667865 BACKGROUND

• Gontero P, Casetta G, Maso G, Sogni F, Pretti G, Zitella A, Frea B, Tizzani A. Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol. 2004 Sep;46(3):339-43. doi: 10.1016/j.eururo.2004.05.001.

  PMID: 15306105 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shahrokh F. Shariat Prof. Dr., Professor

  Department of Urology, Medical University of Viernna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekaterina Laukhtina Dr., Medical Doctor

CONTACT

+43 (0)1 40400-26315; ekaterina.laukhtina@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 13, 2025
• Study Start: December 27, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)