Bladder Cancer Clinical Trial
S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
Summary
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
Full Description
PRIMARY OBJECTIVES:
I. To compare whether time to high grade recurrence (TTHGR) for patients with BCG-naïve, non-muscle invasive bladder cancer (NMIBC) receiving Tokyo-172 BCG strain (Arm II) is non-inferior to patients receiving TICE BCG strain (Arm I).
II. To test whether TTHGR for patients with BCG-naïve, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation (Arm III) is superior to patients receiving intravesical Tokyo-172BCG instillation without prior intradermal BCG vaccination (Arm II).
SECONDARY OBJECTIVES:
I. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between patients receiving Tokyo-172 versus TICE BCG strain.
II. To compare TTR with AG bladder cancer between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.
III. To compare progression-free survival (PFS) between patients receiving Tokyo-172 versus TICE BCG strain.
IV. To compare PFS between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.
V. To compare 6-month complete response in patients with carcinoma in situ (CIS) with or without Ta or T1 cancer present at baseline receiving Tokyo-172 versus TICE BCG strain.
VI. To compare 6-month complete response in patients with CIS with or without Ta or T1 cancer present at baseline receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.
TERTIARY OBJECTIVES:
I. To test the hypothesis that purified protein derivative (PPD) test conversion (positive PPD at 3 or 6 months) following BCG immunotherapy will predict time to high grade recurrence (TTHGR).
II. To test the hypothesis that urinary cytokine levels following BCG immunotherapy will predict time to high grade recurrence (TTHGR).
III. To test the hypothesis that tumor neoantigen burden and T lymphocyte infiltration are associated with BCG response.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I:
INDUCTION: Patients receive TICE BCG solution intravesically once a week for 6 weeks.
MAINTENANCE: Patients receive TICE BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.
ARM II:
INDUCTION: Patients receive Tokyo-172 strain BCG solution intravesically once a week for 6 weeks.
MAINTENANCE: Patients receive Tokyo-172 strain BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.
ARM III:
PRIME: Patients receive Tokyo-172 strain BCG vaccine once intradermally (ID).
INDUCTION: Within 21 days, patients receive Tokyo-172 strain BCG solution as in Arm II.
MAINTENANCE: Patients receive Tokyo-172 strain BCG solution as in Arm II.
After completion of study treatment, patients are followed up for 5 years.
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration
Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration
Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration
Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification
Patients must not have pure squamous cell carcinoma or adenocarcinoma
Patients' disease must not have micropapillary components
Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms
Patients must not have nodal involvement or metastatic disease
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible
Patients must have a Zubrod performance status of 0-2
Patients must not have received prior intravesical BCG
Patients must not have known history of tuberculosis
Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml)
Patients must be >= 18 years of age
Patients must not be taking oral glucocorticoids at the time of registration
Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
Prestudy history and physical must be obtained within 90days prior to registration
Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 135 Locations for this study
Mobile Alabama, 36688, United States
Gilbert Arizona, 85234, United States
Phoenix Arizona, 85054, United States
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Oakland California, 94611, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Sacramento California, 95823, United States
San Francisco California, 94158, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20010, United States
Washington District of Columbia, 20037, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Decatur Georgia, 30033, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Hilo Hawaii, 96720, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Boise Idaho, 83706, United States
Boise Idaho, 83712, United States
Caldwell Idaho, 83605, United States
Fruitland Idaho, 83619, United States
Meridian Idaho, 83642, United States
Nampa Idaho, 83686, United States
Nampa Idaho, 83686, United States
Twin Falls Idaho, 83301, United States
Centralia Illinois, 62801, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Danville Illinois, 61832, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Effingham Illinois, 62401, United States
Mattoon Illinois, 61938, United States
Maywood Illinois, 60153, United States
Mount Vernon Illinois, 62864, United States
O'Fallon Illinois, 62269, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Iowa City Iowa, 52242, United States
Westwood Kansas, 66205, United States
Metairie Louisiana, 70006, United States
Metairie Louisiana, 70006, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Brownstown Michigan, 48183, United States
Clinton Township Michigan, 48038, United States
Dearborn Michigan, 48126, United States
Detroit Michigan, 48202, United States
Lansing Michigan, 48912, United States
Novi Michigan, 48377, United States
Warren Michigan, 48093, United States
West Bloomfield Michigan, 48322, United States
Cape Girardeau Missouri, 63703, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Great Falls Montana, 59405, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89074, United States
Henderson Nevada, 89074, United States
Henderson Nevada, 89074, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89074, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89103, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89113, United States
Las Vegas Nevada, 89113, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89144, United States
Las Vegas Nevada, 89144, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89169, United States
Reno Nevada, 89502, United States
Basking Ridge New Jersey, 07920, United States
Englewood New Jersey, 07631, United States
Middletown New Jersey, 07748, United States
Buffalo New York, 14263, United States
Commack New York, 11725, United States
Elmira New York, 14905, United States
Harrison New York, 10604, United States
New York New York, 10016, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Uniondale New York, 11553, United States
Chapel Hill North Carolina, 27599, United States
Beavercreek Ohio, 45431, United States
Columbus Ohio, 43210, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73120, United States
Coos Bay Oregon, 97420, United States
Medford Oregon, 97504, United States
Ontario Oregon, 97914, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19107, United States
Boiling Springs South Carolina, 29316, United States
Charleston South Carolina, 29401, United States
Clinton South Carolina, 29325, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Dallas Texas, 75390, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
League City Texas, 77573, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Farmington Utah, 84025, United States
Salt Lake City Utah, 84112, United States
South Jordan Utah, 84009, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98431, United States
Morgantown West Virginia, 26506, United States
Chippewa Falls Wisconsin, 54729, United States
Eau Claire Wisconsin, 54701, United States
La Crosse Wisconsin, 54601, United States
Ladysmith Wisconsin, 54848, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Minocqua Wisconsin, 54548, United States
Rice Lake Wisconsin, 54868, United States
Stevens Point Wisconsin, 54482, United States
Wausau Wisconsin, 54401, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
How clear is this clinincal trial information?