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Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

NCT01731652•Telormedix SA

Summary

This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.

Detailed Description

This study is an open label, pilot study of TMX-101 in the treatment of carcinoma in situ. TMX-101 is a new formulation of Imiquimod optimized for intravesical delivery. Imiquimod possesses immune-stimulatory properties. TMX-101 is being developed as a potential treatment for patients with non-invasive bladder cancer, including patients with CIS bladder cancer. Following confirmation of CIS by histology, patients will receive weekly instillations of TMX-101 for 6 weeks. Five to seven weeks after the last instillation, biopsies and cytology will be performed. Response to treatment will be determined based on cytology and tissue sample histology findings.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or female patient is aged ≥18 years.
•2. Pathologically-proven, recurrent, primary, secondary or concomitant carcinoma in situ disease, defined by having either Ta or T1 with CIS, or CIS alone. In cases with T1 tumor lesions, muscularis propria tissue should be in the resected specimen to confirm that it is tumor-free.
•3. Patient has undergone mapping of the bladder between Days -28 and -14, with at least one biopsy providing pathological confirmation of CIS of the bladder. Slides must be available for a central pathology review.
•4. Patient has undergone bladder washing for cytology between Days -28 and -1. In patients in whom Ta or T1 lesion(s) were resected, the bladder washing must have occurred after the resection. Slides must be available for a central cytology review.
•5. Patient has an ECOG performance status 0-2.
•6. Patient has adequate bone marrow, hepatic, and renal function within 4 weeks before Day 0.
•7. Patient has read and understood the informed consent form and is willing and able to give informed consent.
•8. Patient fully understands the requirements of the study and is willing to comply with all study visits and assessments.
•9. If a woman of childbearing potential (WCBP), patient has a negative blood pregnancy test at the Screening visit. For the purposes of this study, WCBP is defined as a post-pubescent female, unless post-menopausal for at least 2 years, surgically sterile, or sexually inactive.
•10. If patient is a WCPB or male patient with a female partner of childbearing potential, must be willing to avoid pregnancy by using an adequate method of contraception from 2 weeks before through 4 weeks after the last study drug treatment. Adequate contraception is defined as follows: 2 barrier methods or 1 barrier method with a spermicide or intrauterine device.

Exclusion Criteria

•1. Patient has evidence of muscle-invasive disease (i.e., T2 or higher)
•2. In the Investigator's opinion, patient is not able to hold instillation for at least 1 hour.
•3. In the Investigator's opinion, patient cannot tolerate intravesical administration or intravesical surgical manipulation.
•4. Patient has received radiation therapy of pelvis within 12 months before the first study drug treatment.
•5. Patient requires perioperative intravesical chemotherapy.
•6. Patient has a history of malignancy of the upper urinary tract.
•7. Patient has bone marrow impairment as evidenced by:
•* Hemoglobin \<9.0 g/dL
•* Absolute neutrophil count (ANC) \<1.5×109/L
•* Platelet count \<120×109/L.
+13 more criteria

Locations (4)

BCG Oncology

Phoenix, Arizona, United States

The Urology Center of Colorado

Denver, Colorado, United States

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

February 1, 2014

Completion Date

October 1, 2014

Last Updated

February 10, 2015

Enrollment

ACTUAL participants

Conditions

Carcinoma in SituNon Muscle Invasive Bladder Cancer

Interventions

TMX-101

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Inclusion Criteria

Exclusion Criteria

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