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Carcinoma in SituPhase 2NCT01731652

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

A Phase 2 study testing TMX-101 in people with Carcinoma in Situ and Non Muscle Invasive Bladder Cancer, run by Telormedix SA at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TMX-101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesUnited States
Study dates
Feb 2013to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or female patient is aged ≥18 years.
  • 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.
  • 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.
  • 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.
  • Patient has an ECOG performance status 0-2.
  • Patient has adequate bone marrow, hepatic, and renal function within 4 weeks before Day 0.
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  • Patient has read and understood the informed consent form and is willing and able to give informed consent.
  • Patient fully understands the requirements of the study and is willing to comply with all study visits and assessments.
  • 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.
  • 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.

Who cannot join

  • Patient has evidence of muscle-invasive disease (i.e., T2 or higher)
  • In the Investigator's opinion, patient is not able to hold instillation for at least 1 hour.
  • In the Investigator's opinion, patient cannot tolerate intravesical administration or intravesical surgical manipulation.
  • Patient has received radiation therapy of pelvis within 12 months before the first study drug treatment.
  • Patient requires perioperative intravesical chemotherapy.
  • Patient has a history of malignancy of the upper urinary tract.
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  • 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.
  • Patient has renal impairment, as evidenced by:
  • Serum creatinine >2× the upper limit of normal (ULN), and/or
  • Calculated creatinine clearance <40 mL/min.
  • Patient has liver function abnormality, as evidenced by:
  • Total bilirubin >1.5×ULN, or
  • Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) >2.5×ULN.
  • Patient has a bleeding disorder, as evidenced by an international normalized ratio (INR) >1.5×ULN.
  • Patient is known to be positive for human immunodeficiency virus (HIV) or has active hepatitis B or C infection.
  • Patient has a clinically significant active infection at the time of the first study drug treatment.
  • 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.
  • Patient has suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407, hydroxy propyl betacyclodextrin, or lactic acid.
  • If female, patient is pregnant or breast feeding.
  • Patient participated in any other protocol involving administration of an investigational agent within 3 months before Day 0.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Urologic Consultants of SE PA

    Bala-Cynwyd, Pennsylvania, 19004

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • BCG Oncology

    Phoenix, Arizona, 85032

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
TMX-101
Keywords
bladder cancer, carcinoma in situ, non muscle invasive bladder cancer
Medical subject headings
Carcinoma in Situ, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMX-101Drug

    Also called Imiquimod

Study groups in NCT01731652
Study groupRoleWhat they receive
TMX-101ExperimentalTMX-101 0.4% (200 mg in 50 ml) instilled in the bladder once weekly for 6 weeks
Receives: Drug: TMX-101

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 to 7 weeks after the last TMX -101 instillation

Secondary outcomes (1)

  1. Proportion of patients experiencing adverse events (AEs), including serious adverse events (SAEs) and AEs leading to discontinuation from the study.

    Measured: Patients will be followed through treatment and follow-up, for an expected total period of up to 13 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01731652
Sponsor's protocol ID
TMX-101-003
Status last verified
Feb 2015
First submitted
12 Nov 2012
Last updated
10 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Donin NM, Chamie K, Lenis AT, Pantuck AJ, Reddy M, Kivlin D, Holldack J, Pozzi R, Hakim G, Karsh LI, Lamm DL, Belkoff LH, Belldegrun AS, Holden S, Shore N. A phase 2 study of TMX-101, intravesical imiquimod, for the treatment of carcinoma in situ bladder cancer. Urol Oncol. 2017 Feb;35(2):39.e1-39.e7. doi: 10.1016/j.urolonc.2016.09.006. Epub 2016 Oct 26.

    PubMed 28341495

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMX-101 in people with Carcinoma in Situ and Non Muscle Invasive Bladder Cancer, run by Telormedix SA at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01731652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.

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