CPG 7909 in Patients Wih Stage IV Renal Cell Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

August 8, 2002

Last Updated Date

February 11, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exam, EKG’s
Efficacy: Tumor response, time-to-progression, duration of responses, immunologic activity, performance status, survival

Change History

Complete list of historical versions of study NCT00043407 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

CPG 7909 in Patients Wih Stage IV Renal Cell Cancer

Official Title ^ICMJE

A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Renal Cell

Intervention ^ICMJE

Drug: CPG 7909

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2004

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00043407

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

C010, CO10, A8501022

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP