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Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-Refractory Patients With Non-Muscle Invasive Bladder Cancer
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III, Phase II
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Diagnostic, Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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HIS-0611-0602
NCT00406068
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Trial Description
Summary The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG). Further Study Information The study will be divided into 3 phases: Induction, Maintenance, and Follow-up. The Induction Phase will cover a period of 6 weeks. During this time, patients will receive 6 weekly intravesical instillations of 8 mg MCC. The patients will be evaluated at month 3, at which time the patients will enter the Maintenance Phase. The Maintenance Phase will last from month 3 to month 24, and during this time, patients will receive weekly MCC instillations for three weeks at months 3, 6, 12, 18, and 24 and evaluations will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24. At month 3, the patient will be evaluated to assure that the disease is not progressing. Cytology, cystoscopy and biopsies will be performed to obtain adequate staging (if residual tumor persists). If the patient is disease-free, maintenance therapy will be initiated. Patients with non-muscle invasive tumors at month 3 will, at the discretion of the investigator, receive either a second 6-week induction course or a 3-week maintenance course. Patients who show progression to muscle invasive disease will be referred to other treatments. At month 6 and thereafter at each evaluation visit, patients will be evaluated and managed according to the following results: - Patients who are disease-free will continue on maintenance treatment.
- Patients who are not disease-free (evidence of papillary lesions, CIS or muscle invasive disease) will be withdrawn from further study treatment and will be referred to other therapies at the discretion of the investigator.
The final 36 months of the study is the Follow-up Phase. Evaluations will be performed at months 30, 36, 42, 48, 54 and 60. Efficacy evaluations will include standard cystoscopy, biopsies and urine cytology. During the Maintenance Phase, standard cystoscopies will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24 for the surveillance of bladder tumors. During the months that instillations will be performed, cystoscopies will be conducted only once at each of these months. During the Follow-up Phase, cystoscopies will be performed at months 30, 36, 42, 48, 54 and 60. Mandatory bladder biopsies will be done for all patients at month 6. During the course of the study, biopsies will be taken only if evident or suspicious lesions are seen during cystoscopy or in case of negative cystoscopy but positive cytology. Eligibility Criteria Inclusion Criteria: - Patients refractory to BCG therapy;
- Patients with histologically confirmed diagnosis of high grade lesions;
- Diagnosis of high grade lesion must be within 56 days prior to beginning of study treatment;
- Have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;
- Available for the whole duration of the study including follow-up (60 months);
- Life expectancy of > 5 years;
- Patients with an ECOG performance status grade of 2 or less;
- Absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from beginning of study treatment;
- Able to understand and give written informed consent;
- In the investigator's judgment, the patient is able to participate in the study.
Exclusion Criteria: - Current or previous history of muscle invasive tumors;
- Current or previous history of lymph node or distant metastases from bladder cancer;
- Current systemic cancer therapy;
- Current or prior pelvic external beam radiotherapy;
- Pelvic brachytherapy within 2 years of study entry;
- Prior treatment with MCC;
- Patients with existing urinary tract infection or recurrent severe bacterial cystitis;
- Clinically significant and unexplained elevations of liver or renal function tests;
- White blood cell count below 3 x109/L (3,000/mm3) or platelet count below 100 x 109/L(100,000/mm3);
- Severe cardiovascular disease;
- Women who are pregnant or lactating;
- Congenital or acquired immune deficiency;
- With history of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, stage T1 prostate cancer, carcinoma in situ of the cervix or colon polyps);
- Previous investigational treatment within 3 months from beginning of study treatment;
- Patients who cannot hold the instillation for one hour;
- Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy);
- Clinically significant active infections;
- Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol.
Trial Contact Information
Trial Lead Organizations/Sponsors Bioniche Life Sciences, Incorporated | Alvaro Morales, MD | | Principal Investigator |
Trial Sites
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| U.S.A. |
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| Arizona |
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Phoenix |
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| | | | | | | | Bladder Cancer Genitourinary Oncology, PC |
| | | Donald Lamm, MD |
Ph: 602-493-6626 |
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Email:
dlamm@bcgoncology.com |
| | | Mary Heeley |
Ph: (602) 923-1327 |
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Email:
mary@bcgoncology.com |
| | | Donald L. Lamm | Principal Investigator |
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| California |
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San Diego |
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| | | | San Diego Clinical Trials |
| | | Monica Torres, CRC |
Ph: 619-287-6000 |
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Email:
monicatorres@sdclinicaltrials.com |
| | | Jenny Burton, CRC |
Ph: (619) 287-6000 |
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Email:
jenniferburton@sdclinicaltrials.com |
| | | Mohamed Bidair, MD | Principal Investigator |
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| Connecticut |
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New Britain |
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| | | | Connecticut Urological Research at Grove Hill |
| | | Lihi Brocke, Ph.D. |
Ph: 860-826-4453 Ext.5276 |
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Email:
lbrocke@grovehill.com |
| | | Rafael Wurzel, MD | Principal Investigator |
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| Florida |
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Miami |
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| | | | University of Miami Sylvester Comprehensive Cancer Center - Miami |
| | | Dinorah Rodriguez, RN |
Ph: 305-243-7207 |
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Email:
drodriguez5@med.miami.edu |
| | | Mark Soloway, MD | Principal Investigator |
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Orlando |
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| | | Winter Park Urology Associates, PA |
| | | Sharon Livingstone, R.N. |
Ph: 407-992-2673 |
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Email:
sharonlivingstone@wpuafl.com |
| | | Felipe Valerio, MA |
Ph: (407) 992-3170 |
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Email:
felipevalerio@wpuafl.com |
| | | David Jablonski, MD | Principal Investigator |
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| Illinois |
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Chicago |
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| | | | University of Chicago Cancer Research Center |
| | | Josephine Silvestre, RN |
Ph: 773-702-0792 |
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Email:
jsilvest@surgery.bsd.uchicago.edu |
| | | Gary Steinberg, MD |
Ph: (773) 702-3080 |
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Email:
gsteinbe@surgery.bsd.uchicago.edu |
| | | Gary Steinberg, MD | Principal Investigator |
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| Indiana |
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Evansville |
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| | | | Welborn Clinic |
| | | Christina Burkes, LPN |
Ph: 812-474-4593 |
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Email:
burkesc@welbornclinic.com |
| | | Madeline Bryant |
Ph: (812) 426-9737 |
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Email:
bryantm@welbornclinic.com |
| | | Paul Siami, MD | Principal Investigator |
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| Maryland |
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Baltimore |
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| | | | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| | | Tina Driscoll, CCRC |
Ph: 410-955-0163 |
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Email:
twlajnitz@jhmi.edu |
| | | Mark Schoenberg, MD |
Ph: (410) 955-1039 |
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Email:
mschoenberg@jhmi.edu |
| | | Mark Schoenberg, MD | Principal Investigator |
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Towson |
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| | | Chesapeake Urology Research Associates |
| | | Debra Robertson |
Ph: 410-825-6310 Ext.163 |
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Email:
drobertson@cua.md |
| | | Ronald Tutrone, MD | Principal Investigator |
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| Nevada |
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Las Vegas |
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| | | | Sheldon J Freedman, MD, Ltd |
| | | Cynthia Freedman, R.N. |
Ph: 702-732-0282 Ext.251 |
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Email:
cwfreedman@aol.com |
| | | Nara Pagliarulo |
Ph: (702) 732-0282 Ext.221 |
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Email:
Npagliaruloclinicalresearch@yahoo.com |
| | | Sheldon Freedman, MD | Principal Investigator |
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| New Jersey |
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Voorhees |
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| | | | Center for Urologic Care at Centennial Medical Center |
| | | Catherine Kavalchick, R.N. |
Ph: 856-751-5288 |
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Email:
ckavalchick@dvullc.com |
| | | Marilyn Behler |
Ph: (856) 985-8000 |
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Email:
mbehler@dvullc.com |
| | | Louis Keeler, MD | Principal Investigator |
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| New York |
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Garden City |
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| | | | Urological Surgeons of Long Island, PC |
| | | Marisa Mitnik, R.N. |
Ph: 516-742-3200 Ext.201 |
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Email:
marisaschulman@yahoo.com |
| | | Vincent Gandolfo, P.A. |
Ph: (516) 742-3200 Ext.123 |
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Email:
golmy@aol.com |
| | | Barry Shepard, MD | Principal Investigator |
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New York |
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| | | Memorial Sloan-Kettering Cancer Center |
| | | Harry Herr, MD |
Ph: 646-422-4411 |
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Email:
herrh@mskcc.org |
| | | Guido Dalbagni, MD |
Ph: (646) 422-4394 |
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Email:
dalbagnig@mskcc.org |
| | | Harry Herr, MD | Principal Investigator |
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Poughkeepsie |
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| | | Hudson Valley Urology, PC |
| | | Laurel Gross, RT |
Ph: 845-437-5052 |
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Email:
lgross@hvubest.com |
| | | Lorraine O'Donnell, RN, CCRC |
Ph: (845) 437-5000 Ext.1009 |
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Email:
lodonnell@hvubest.com |
| | | Evan Goldfischer, MD | Principal Investigator |
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Rochester |
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| | | James P. Wilmot Cancer Center at University of Rochester Medical Center |
| | | Elizabeth M Smith, BSc, CCRC |
Ph: 585-275-0989 |
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Email:
betty_smith@urmc.rochester.edu |
| | | Britton Wage, RN |
Ph: (585) 275-0731 |
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Email:
britton_wage@urmc.rochester.edu |
| | | Edward Messing, MD | Principal Investigator |
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| Pennsylvania |
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Pittsburgh |
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| | | | Triangle Urological Group |
| | | Chantal Mitchell, LPN |
Ph: 412-246-2458 |
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Email:
cmitchell@triangleurology.com |
| | | Jeffrey K Cohen, MD | Principal Investigator |
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| Tennessee |
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Nashville |
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| | | | Vanderbilt-Ingram Cancer Center |
| | | Pamela Steele, BSN |
Ph: 615-343-2120 |
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Email:
Pamela.steele@vanderbilt.edu |
| | | Victoria Sandlin, BSN |
Ph: (615) 343-5633 |
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Email:
victoria.sandlin@vanderbilt.edu |
| | | Sam Chang, MD | Principal Investigator |
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| Texas |
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Dallas |
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| | | | Urology Clinics of North Texas, P.A. |
| | | Ami Bosley |
Ph: 214-580-1482 |
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Email:
Bosley@urologyclinics.com |
| | | Tahmineh Bahrami-Behtash, MSc |
Ph: (214) 691-1902 Ext.2121 |
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Email:
Behtash@urologyclinics.com |
| | | James Cochran, MD | Principal Investigator |
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Houston |
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| | | M. D. Anderson Cancer Center at University of Texas |
| | | GU Protocol Information Line |
Ph: 713-563-1602 |
| | | Ashish Kamat, MD | Principal Investigator |
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San Antonio |
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| | | Urology San Antonio, PA - Fredericksburg |
| | | Guillermo Espino, B.Sc. |
Ph: 210-477-8839 |
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Email:
guillermo.espino@urologysaresearch.com |
| | | Gary Brown, B.Sc. |
Ph: (210) 477-8839 |
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Email:
gary.brown@urologysaresearch.com |
| | | Daniel R. Saltzstein | Principal Investigator |
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| Virginia |
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Norfolk |
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| | | | Urology of Virginia - Norfolk |
| | | Jennifer Kucenski, RN |
Ph: 757-457-5123 |
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Email:
jekucens@sentara.com |
| | | Jackie Cruse |
Ph: (757) 457-5169 |
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Email:
ljbcruse@sentara.com |
| | | Robert Given, MD | Principal Investigator |
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| Canada |
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| British Columbia |
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Surrey |
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| | | | | CMX Research, Incorporated - Surrey |
| | | Wendy Largy, RN |
Ph: (604) 583-2271 |
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Email:
wendy.andreou@telus.net |
| | | Cal Andreou | Principal Investigator |
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Victoria |
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| | | Can-Med Clinical Research, Incorporated |
| | | Peter J Pommerville, M.D., FRCSC |
Ph: (250) 370-2606 |
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Email:
ppomm@pommerville-urology.com |
| | | Maureen Murray, M.D. |
Ph: (250) 370-2606 |
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Email:
maureen@can-med.ca |
| | | Peter J Pommerville, MD, FRCSC | Principal Investigator |
| | | Dr. Steinhoff Clinical Research |
| | | Jayne Forster-Coull, RN, CRC |
Ph: (250) 388-0840 |
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Email:
jayne@gsteinhoff.com |
| | | Catherine Douglas, RN, CRC |
Ph: (250) 388-0840 |
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Email:
catherine@gsteinhoff.com |
| | | Gary Steinhoff, MD | Principal Investigator |
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| Ontario |
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Kingston |
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| | | | Kingston General Hospital |
| | | Laurel Emerson, RN, CCRP |
Ph: (613) 548-6033 |
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Email:
emersonl@kgh.kari.net |
| | | Sylvia Robb, RN, CPC(C) |
Ph: (613) 548-7800 |
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Email:
robbs@kgh.kari.net |
| | | Alvaro Morales, MD | Principal Investigator |
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London |
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| | | London Regional Cancer Program at London Health Sciences Centre |
| | | Wendy Shoff, RN |
Ph: (519) 685-8500 Ext.57350 |
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Email:
wendy.shoff@lhsc.on.ca |
| | | Joseph Chin, MD | Principal Investigator |
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Toronto |
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| | | Edmond Odette Cancer Centre at Sunnybrook |
| | | Irene McNeill |
Ph: (416) 480-6400 Ext.2431 |
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Email:
irene.mcneill@sunnybrook.ca |
| | | Marlene Kebabdjian, CRC |
Ph: (416) 480-6100 Ext.2890 |
| | | Laurence H. Klotz | Principal Investigator |
| | | Male Health Centre - North York |
| | | Shelley Burton, RN |
Ph: (416) 256-9606 |
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Email:
tucsg@hotmail.com |
| | | Jack Barkin, MD | Principal Investigator |
| | | Princess Margaret Hospital |
| | | Joan Basiuk, RN |
Ph: (416) 946-4501 Ext.2282 |
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Email:
joan.basiuk@uhn.on.ca |
| | | Iwona Link |
Ph: (416) 946-4501 |
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Email:
iwona.link@uhn.on.ca |
| | | Michael Jewett, MD | Principal Investigator |
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| Quebec |
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Montreal |
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| | | | CHUM - Hotel Dieu Hospital |
| | | Josette Bergeron, RN |
Ph: (514) 890-8000 Ext.35817 |
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Email:
josette.bergeron.chum@ssss.gouv.qc.ca |
| | | Paul Perrotte, MD | Principal Investigator |
| | | Jewish General Hospital - Montreal |
| | | Wendella Hamilton |
Ph: (514) 735-9981 Ext.105 |
| | | Contact Person |
Ph: (514) 340-8222 Ext.1627 |
| | | Serge Carrier, MD | Principal Investigator |
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Quebec City |
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| | | Centre de Recherche du CHUQ |
| | | Denyse L'Hereault, RN |
Ph: (418) 691-5050 |
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Email:
elizabeth.lemay@crhdq.ulaval.ca |
| | | Louis Lacombe, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00406068
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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