Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00880854
• Other study ID #: CO08807
• Secondary ID: NCI-2011-03676H-
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2009

Study information

• Verified date: November 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG.

• Evidence of disease recurrence within 1 year of previous BCG treatment

• Tumor tissue must be available from biopsy for study related immunohistochemical analysis

• If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment

• ECOG performance status of <2

• Life expectancy of at least 6 months

• Adequate hematologic, renal and liver function

• Informed consent

Exclusion Criteria:

• No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months

• No prior radiation to the pelvis

• No gross hematuria within 1 week prior to planned week 1 treatment

• Cannot have previous intolerance to BCG

• Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history

• No evidence of metastatic disease

• No prior treatment with anti-CTLA-4 monoclonal antibody

• Can not be pregnant or lactating

• No history of autoimmune disorder

• No history of thyroid or adrenal insufficiency

• No history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, Crohn's or celiac disease, intractable urinary tract infection

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• BCG and CP-675,206
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses		24 months
Secondary	To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes		24 months
Secondary	To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses		24 months
Secondary	To determine the 1-year recurrence-free survival		24 months
Secondary	To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose		24 months

External Links

•   University of Wisconsin Carbone Cancer Center