S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03091660 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : May 3, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stage 0 Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma | Biological: BCG Solution Biological: BCG Tokyo-172 Strain Solution Biological: BCG Tokyo-172 Strain Vaccine Other: Laboratory Biomarker Analysis | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer |
Actual Study Start Date : | February 24, 2017 |
Estimated Primary Completion Date : | December 15, 2024 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm I (BCG solution)
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.
|
Biological: BCG Solution
Given intravesically
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
Experimental: Arm II (Tokyo-172 strain BCG solution)
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.
|
Biological: BCG Tokyo-172 Strain Solution
Given intravesically
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
Experimental: Arm III (Tokyo-172 strain BCG solution with priming)
PRIME: Patients receive Tokyo-172 strain BCG vaccine once 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.
|
Biological: BCG Tokyo-172 Strain Solution
Given intravesically
Other Names:
Biological: BCG Tokyo-172 Strain Vaccine Given ID
Other Name: Bacillus Calmette-Guerin Tokyo-172 Strain Vaccine Other: Laboratory Biomarker Analysis Correlative studies |
- TTHGR for Arm I compared to Arm II [ Time Frame: Time from randomization to first high grade recurrence assessed up to 5 years ]Time to High Grade Recurrence
- TTHGR for Arm II compared to Arm III [ Time Frame: Time from randomization to first high grade recurrence assessed up to 5 years ]Time to High Grade Recurrence
- Disease free rates [ Time Frame: At 6 months ]Rates of patients who are disease free at six months versus not
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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091660
Principal Investigator: | Robert Svatek | SWOG Cancer Research Network |
Responsible Party: | SWOG Cancer Research Network |
ClinicalTrials.gov Identifier: | NCT03091660 |
Other Study ID Numbers: |
S1602 NCI-2016-00451 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S1602 ( Other Identifier: SWOG ) S1602 ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract ) |
First Posted: | March 27, 2017 Key Record Dates |
Last Update Posted: | May 3, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | https://swog.org/Visitors/Download/Policies/Policy43.pdf |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Transitional Cell Non-Muscle Invasive Bladder Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Pharmaceutical Solutions Vaccines BCG Vaccine Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |