Bladder CancerNCT01007058
Markers of Response to Intravesical Bladder Cancer Therapy
An observational study of Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this laboratory research study is to see if researchers can predict whose cancer will stay in remission and whose will return in patients receiving treatment for bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Apr 2016
- Phase
- Observational
- 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
Study population: Bladder cancer patients, 18 years or older, who will be receiving treatment with BCG or BCG + Interferon at UT MD Anderson Cancer Center.
Who may be able to join
- Disease Characteristics:
- Histologically confirmed primary or recurrent non-muscle-invasive transitional cell carcinoma with an intact bladder
- Stage Ta, T1, or carcinoma in situ
- Grade 1, 2, or 3
- Primary disease site must be the urinary bladder
- No evidence of tumor invasion of the muscularis propria by cystoscopy and biopsy within the past 6 weeks
Show all 24Show fewer
- Upper tract imaging within the prior 12 months
- Patient Characteristics:
- Age: 18 years and above
- Gender: Male or female
- Life expectancy: 24 months or greater
- Performance status: 0 - 1
- Prior Therapy:
- Biologic therapy: allowed
- Chemotherapy: allowed
- Radiotherapy: no prior pelvic radiotherapy
- Surgery: recovered from prior transurethral resection
- Intravesical Immunotherapy:
- In the opinion of the treating physician, the patient must be a candidate for "standard of care" intravesical immunotherapy, defined as
- Induction with 6 weekly treatments of intravesical BCG followed by maintenance with 3 weekly treatments of intravesical BCG at 3 months. Continued maintenance therapy at 6 months and then every 6 months for total of 36 months ("Lamm regimen") (38) is optional and left to the discretion of the physician or
- Induction with 6 weekly treatments of intravesical BCG plus IFN-alfa-2b followed by maintenance with 3 weekly treatments of BCG plus IFN-alfa-2b at 3 months. Continued maintenance therapy at 9 months, and 15 months ("O'Donnell regimen") (39) is optional and left to the discretion of the physician.
- Patients will be included in the study based on 'intent to treat'. If, after start of induction, the treating physician decides to alter the treatment regimen, patients will still be included for analysis.
- Special Situations:
- A special situation arises when during the course of the study, a patient develops recurrent tumor, and is deemed by the treating physician to require either a reinduction course of BCG therapy or therapy with BCG plus Interferon. In that case, the patient will remain in the protocol and, since urine cytology/FISH and cytokine responses are dependent on the treatment time-table, we will start collecting urine samples all over again, as already described previously in the protocol. Also, starting from the change in the treatment plan, the patient's overall time in the protocol will be prolonged up to the completion of a 24-month period of time.
Who cannot join
- Ongoing Pregnancy
- Patients who are not eligible to receive standard-of-care intravesical immunotherapy such as
- histologically confirmed pure squamous cell carcinoma or pure adenocarcinoma,
- patients with nonurothelial bladder cancer such as sarcoma, and immunocompromised patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this laboratory research study is to see if researchers can predict whose cancer will stay in remission and whose will return in patients receiving treatment for bladder cancer.
Read the detailed description
In this study, researchers are looking at markers that they could use to identify - at an early time point - those patients who might not respond to this treatment. This would allow researchers to provide future patients with information about their chances of responding to such treatment. And, with this information, researchers could better counsel those patients who might benefit from a different therapy at an earlier time point.
Treatment with BCG or BCG plus interferon is currently the most effective nonsurgical treatment for superficial bladder cancer. However, at this time, there is no reliable test that can help researchers predict which patients will respond to this therapy. You will be receiving BCG or BCG plus interferon therapy as planned by your physician. This is a standard therapy that will be decided by your doctor and based on your disease characteristics. If you agree to take part in this study, your participation will not affect the treatment you will receive in any way. Your follow-up and disease monitoring will be done according to standard routines.
By participating in this study, you agree to provide researchers with 4 tablespoons (or as much as you can produce) of urine at the following time points.
- Before you start therapy.
- Just before and 4 hours after your last treatment (which usually occurs 6 weeks after start of treatment).
- Just before and 4 hours after your last treatment of the second course of therapy (which is usually about 3 months after the beginning of the first course of therapy.
In addition, you will provide researchers with a bladder wash sample. This sample will be collected during routine catheterization (for your planned treatment) or during your routine cystoscopic exam. Bladder wash samples will be collected at the following time points.
- Before you start therapy.
- Just before your last treatment (which usually occurs 6 weeks after start of treatment).
- At your first routine cystoscopic follow-up (which usually occurs at 3 months).
- At your second routine cystoscopic follow-up (which usually occurs at 6 months).
Your follow-up cystoscopies and maintenance therapy will be done according to routine care as decided by your doctor and are not affected by your participation in this study. You will be part of the study for about 24 months after beginning the treatments. At the end of that period, between 23 and 27 months, you will be checked with cystoscopy and cytology to see if the tumor has come back, as part of standard of care.
In addition, information will be collected from your medical chart about other medications that you are taking and other conditions, such as diabetes or heart disease, that you may have. Information will also be collected about previous treatment that you have had for bladder cancer as well as other treatments that you may receive during this study. This may include treatments that are received at an outside health facility. Neither your name nor your medical record number will be kept with this information. All of the information collected for this study will be kept in a locked cabinet to which only the researchers have access. Upon completion of the study, the information sheets will be destroyed.
This is an investigational study.
A total of 300 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Bladder Cancer
- Keywords
- Urinary Bladder, Non-muscle-invasive transitional cell carcinoma, Intact bladder, Intravesical Bladder Cancer Therapy, Tumor Recurrence, Surrogate markers of response, BCG, Bacillus Calmette Guérin, Interferon-alfa-2b, IFN-alfa-2b, Interferon, Fluorescence in situ hybridization, FISH
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Response Markers | Urine Collection and Bladder wash of Bladder Cancer Patients with Treatment of BCG or BCG plus interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startJun 2005
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Ashish M. Kamat, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007058
- Sponsor's protocol ID
- LAB05-0326
- Status last verified
- Dec 2016
- First submitted
- 2 Nov 2009
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamat AM, Briggman J, Urbauer DL, Svatek R, Nogueras Gonzalez GM, Anderson R, Grossman HB, Prat F, Dinney CP. Cytokine Panel for Response to Intravesical Therapy (CyPRIT): Nomogram of Changes in Urinary Cytokine Levels Predicts Patient Response to Bacillus Calmette-Guerin. Eur Urol. 2016 Feb;69(2):197-200. doi: 10.1016/j.eururo.2015.06.023. Epub 2015 Jun 25.
PubMed 26119560
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Response to Intravesical Bladder Cancer Therapy
- ClinicalTrials.gov ID
- NCT01007058
- Acronym / sponsor ID
- LAB05-0326
- Conditions
- Bladder Cancer
- Keywords
- Urinary Bladder, Non-muscle-invasive transitional cell carcinoma, Intact bladder, Intravesical Bladder Cancer Therapy, Tumor Recurrence, Surrogate markers of response, BCG, Bacillus Calmette Guérin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Study start
- Jun 2005
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this laboratory research study is to see if researchers can predict whose cancer will stay in remission and whose will return in patients receiving treatment for bladder cancer.
Detailed description
In this study, researchers are looking at markers that they could use to identify - at an early time point - those patients who might not respond to this treatment. This would allow researchers to provide future patients with information about their chances of responding to such treatment. And, with this information, researchers could better counsel those patients who might benefit from a different therapy at an earlier time point.
Treatment with BCG or BCG plus interferon is currently the most effective nonsurgical treatment for superficial bladder cancer. However, at this time, there is no reliable test that can help researchers predict which patients will respond to this therapy. You will be receiving BCG or BCG plus interferon therapy as planned by your physician. This is a standard therapy that will be decided by your doctor and based on your disease characteristics. If you agree to take part in this study, your participation will not affect the treatment you will receive in any way. Your follow-up and disease monitoring will be done according to standard routines.
By participating in this study, you agree to provide researchers with 4 tablespoons (or as much as you can produce) of urine at the following time points.
- Before you start therapy.
- Just before and 4 hours after your last treatment (which usually occurs 6 weeks after start of treatment).
- Just before and 4 hours after your last treatment of the second course of therapy (which is usually about 3 months after the beginning of the first course of therapy.
In addition, you will provide researchers with a bladder wash sample. This sample will be collected during routine catheterization (for your planned treatment) or during your routine cystoscopic exam. Bladder wash samples will be collected at the following time points.
- Before you start therapy.
- Just before your last treatment (which usually occurs 6 weeks after start of treatment).
- At your first routine cystoscopic follow-up (which usually occurs at 3 months).
- At your second routine cystoscopic follow-up (which usually occurs at 6 months).
Your follow-up cystoscopies and maintenance therapy will be done according to routine care as decided by your doctor and are not affected by your participation in this study. You will be part of the study for about 24 months after beginning the treatments. At the end of that period, between 23 and 27 months, you will be checked with cystoscopy and cytology to see if the tumor has come back, as part of standard of care.
In addition, information will be collected from your medical chart about other medications that you are taking and other conditions, such as diabetes or heart disease, that you may have. Information will also be collected about previous treatment that you have had for bladder cancer as well as other treatments that you may receive during this study. This may include treatments that are received at an outside health facility. Neither your name nor your medical record number will be kept with this information. All of the information collected for this study will be kept in a locked cabinet to which only the researchers have access. Upon completion of the study, the information sheets will be destroyed.
This is an investigational study.
A total of 300 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Response Markers | – | –Urine Collection and Bladder wash of Bladder Cancer Patients with Treatment of BCG or BCG plus interferon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bladder cancer patients, 18 years or older, who will be receiving treatment with BCG or BCG + Interferon at UT MD Anderson Cancer Center.
Key inclusion criteria (24 listed)
- Histologically confirmed primary or recurrent non-muscle-invasive transitional cell carcinoma with an intact bladder
- Stage Ta, T1, or carcinoma in situ
- Grade 1, 2, or 3
- Primary disease site must be the urinary bladder
- No evidence of tumor invasion of the muscularis propria by cystoscopy and biopsy within the past 6 weeks
Key exclusion criteria (4 listed)
- Ongoing Pregnancy
- Patients who are not eligible to receive standard-of-care intravesical immunotherapy such as
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Derived from this study: PubMed 26119560Kamat AM, Briggman J, Urbauer DL, Svatek R, Nogueras Gonzalez GM, Anderson R, Grossman HB, Prat F, Dinney CP. Cytokine Panel for Response to Intravesical Therapy (CyPRIT): Nomogram of Changes in Urinary Cytokine Levels Predicts Patient Response to Bacillus Calmette-Guerin. Eur Urol. 2016 Feb;69(2):197-200. doi: 10.1016/j.eururo.2015.06.023. Epub 2015 Jun 25.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish M. Kamat, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site 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 24 inclusion and 4 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy (time frame: Baseline to 24 months). 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 NCT01007058, 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 7 Dec 2016.