CPG 7909 in Patients Wih Stage IV Renal Cell Cancer
A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma
2 other identifiers
interventional
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2002
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 8, 2002
CompletedFirst Posted
Study publicly available on registry
August 12, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFebruary 12, 2009
February 1, 2009
2.5 years
August 8, 2002
February 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Indeterminate
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.
Indeterminate
To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
Indeterminate
Secondary Outcomes (1)
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.
Indeterminate
Study Arms (1)
CPG 7909 Injection
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Stage IV Renal Cell Carcinoma with lung and/or soft tissue metastasis Nephrectomy Measurable disease by RECIST criteria
You may not qualify if:
- CNS, bone or Liver metastasis Tumors that are mainly papillary, chromophobe, medullary, collecting duct, or unclassified Prior immunotherapy, including IL-2 or IFN-alpha
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2002
First Posted
August 12, 2002
Study Start
March 1, 2002
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
February 12, 2009
Record last verified: 2009-02