Back to resultsCPG 7909 in Patients Wih Stage IV Renal Cell Cancer
Primary Purpose
Carcinoma, Renal Cell
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CPG 7909
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Renal Cell Carcinoma, Phase I, Phase II, Immunotherapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CPG 7909 Injection
Arm Description
Outcomes
Primary Outcome Measures
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.
To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
Secondary Outcome Measures
To assess tolerability relative to dose exposure, immunologic activity, the pharmacokinetic and pharmacodynamic profile of CPG 7909 Injection, time to progression, duration of response, and time to survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00043407
Brief Title
CPG 7909 in Patients Wih Stage IV Renal Cell Cancer
Official Title
A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Renal Cell Carcinoma, Phase I, Phase II, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPG 7909 Injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CPG 7909
Other Intervention Name(s)
PF-03512676
Intervention Description
In the phase I portion of the protocol, patients will be included in escalating dose groups: 0.08, 0.12, 0.16, 0.36, 0.54 or 0.81 mg/kg of CPG 7909 Injection. Patients will be treated once weekly subcutaneously for 24 weeks. In the Phase II portion of the trial patients will be treated at the MTD or the highest dose of 0.81 mg/kg identified in the Phase I dose escalation portion of the trial. All patients in Phase I and Phase II will be treated until disease progression or a maximum of 24 weeks.
Primary Outcome Measure Information:
Title
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.
Time Frame
Indeterminate
Title
To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
Time Frame
Indeterminate
Title
To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
Time Frame
Indeterminate
Secondary Outcome Measure Information:
Title
To assess tolerability relative to dose exposure, immunologic activity, the pharmacokinetic and pharmacodynamic profile of CPG 7909 Injection, time to progression, duration of response, and time to survival.
Time Frame
Indeterminate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CO10&StudyName=CPG%207909%20in%20Patients%20wih%20Stage%20IV%20Renal%20Cell%20Cancer
Description
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Learn more about this trial
CPG 7909 in Patients Wih Stage IV Renal Cell Cancer
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