A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell
Both
Carcinoma, Renal Cell
Trial Information
A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma
Inclusion Criteria:
Stage IV Renal Cell Carcinoma with lung and/or soft tissue metastasis Nephrectomy
Measurable disease by RECIST criteria
Exclusion Criteria:
CNS, bone or Liver metastasis Tumors that are mainly papillary, chromophobe, medullary,
collecting duct, or unclassified Prior immunotherapy, including IL-2 or IFN-alpha
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the tolerability of escalating doses of subcutaneously administered CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer.
Outcome Time Frame:
Indeterminate
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
C010
NCT ID:
NCT00043407
Start Date:
March 2002
Completion Date:
September 2004
Related Keywords:
- Carcinoma, Renal Cell
- Renal Cell Carcinoma, Phase I, Phase II, Immunotherapy
- Carcinoma
- Carcinoma, Renal Cell
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