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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03676 | Registry Identifier | NCI Trial ID | |
| H-2008-0227 | Other Identifier | Institutional Review Board | |
| A534260 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/MEDICINE*H | Other Identifier | UW Madison |
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Lack of accrual
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG treatment.
In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG and CP-675,206 | Drug | Dose level -1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 3 mg/kg I.V. week 3, week 15 Dose level 1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 6 mg/kg I.V. week 3, week 15 Dose level 2: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 10 mg/kg IV week 3, week 15 Dose level 3: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 15 mg/kg IV week 3, week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses | 24 months | |
| To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas G McNeel, M.D., Ph.D. | University of Wisconsin, Madison | Principal Investigator |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
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|
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| 24 months |
| To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses | 24 months |
| To determine the 1-year recurrence-free survival | 24 months |
| To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose | 24 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |