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

Phase 2
18 Years
Open (Enrolling)
Carcinoma in Situ, Non Muscle Invasive Bladder Cancer

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR).

Outcome Time Frame:

5 to 7 weeks after the last TMX -101 instillation

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

December 2013

Related Keywords:

  • Carcinoma in Situ
  • Non Muscle Invasive Bladder Cancer
  • bladder cancer
  • carcinoma in situ
  • non muscle invasive bladder cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma in Situ



Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
BCG Oncology Phoenix, Arizona  85032
The Urology Center of Colorado Denver, Colorado  80211
Urologic Consultants of SE PA Bala Cynwyd, Pennsylvania  19004