Markers of Response to Intravesical Bladder Cancer Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01007058
First received: November 2, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition
Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Markers of Response to Intravesical Bladder Cancer Therapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

4 tablespoons of urine and a bladder wash sample during catheterization (for planned treatment) or during routine cystoscopic exam, both samples at 4 different time points before, during and after therapy courses.


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Response Markers
Urine Collection and Bladder wash of Bladder Cancer Patients with Treatment of BCG or BCG plus interferon

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.

  1. Before you start therapy.
  2. Just before and 4 hours after your last treatment (which usually occurs 6 weeks after start of treatment).
  3. 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.

  1. Before you start therapy.
  2. Just before your last treatment (which usually occurs 6 weeks after start of treatment).
  3. At your first routine cystoscopic follow-up (which usually occurs at 3 months).
  4. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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
  • 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.

Exclusion Criteria

  • 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
  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: NCT01007058

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Flight Attendant Medical Research Institute
Investigators
Study Chair: Ashish M. Kamat, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01007058     History of Changes
Other Study ID Numbers: LAB05-0326
Study First Received: November 2, 2009
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014