Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Douglas G McNeel, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO08807

NCT ID:

NCT00880854

Start Date:

June 2009

Completion Date:

June 2012

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • BCG-resistant localized transitional cell of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell

Name

Location