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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01731652
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Telormedix SA

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma in Situ Non Muscle Invasive Bladder Cancer Drug: TMX-101 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: TMX-101
TMX-101 0.4% (200 mg in 50 ml) instilled in the bladder once weekly for 6 weeks
Drug: TMX-101
Other Name: Imiquimod

Primary Outcome Measures :
  1. To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR). [ Time Frame: 5 to 7 weeks after the last TMX -101 instillation ]

Secondary Outcome Measures :
  1. Proportion of patients experiencing adverse events (AEs), including serious adverse events (SAEs) and AEs leading to discontinuation from the study. [ Time Frame: Patients will be followed through treatment and follow-up, for an expected total period of up to 13 weeks. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  8. Patient has renal impairment, as evidenced by:

    • Serum creatinine >2× the upper limit of normal (ULN), and/or
    • Calculated creatinine clearance <40 mL/min.
  9. Patient has liver function abnormality, as evidenced by:

    • Total bilirubin >1.5×ULN, or
    • Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) >2.5×ULN.
  10. Patient has a bleeding disorder, as evidenced by an international normalized ratio (INR) >1.5×ULN.
  11. Patient is known to be positive for human immunodeficiency virus (HIV) or has active hepatitis B or C infection.
  12. Patient has a clinically significant active infection at the time of the first study drug treatment.
  13. Patient has any medical or psychiatric condition that, in the Investigator's opinion, might impair the patient's well-being or preclude adherence to the protocol or completing the study as per protocol.
  14. Patient has suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407, hydroxy propyl betacyclodextrin, or lactic acid.
  15. If female, patient is pregnant or breast feeding.
  16. Patient participated in any other protocol involving administration of an investigational agent within 3 months before Day 0.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01731652

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United States, Arizona
BCG Oncology
Phoenix, Arizona, United States, 85032
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Pennsylvania
Urologic Consultants of SE PA
Bala Cynwyd, Pennsylvania, United States, 19004
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Sponsors and Collaborators
Telormedix SA
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Telormedix SA Identifier: NCT01731652    
Other Study ID Numbers: TMX-101-003
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Telormedix SA:
bladder cancer
carcinoma in situ
non muscle invasive bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers