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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Telormedix SA
ClinicalTrials.gov Identifier:
NCT01731652
First received: November 12, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Carcinoma in Situ
Non Muscle Invasive Bladder Cancer
Drug: TMX-101
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Telormedix SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731652

Locations
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
  More Information

No publications provided

Responsible Party: Telormedix SA
ClinicalTrials.gov Identifier: NCT01731652     History of Changes
Other Study ID Numbers: TMX-101-003
Study First Received: November 12, 2012
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Telormedix SA:
bladder cancer
carcinoma in situ
non muscle invasive bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma in Situ
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 21, 2014