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CPG 7909 in Patients Wih Stage IV Renal Cell Cancer

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ClinicalTrials.gov Identifier: NCT00043407
Recruitment Status : Completed
First Posted : August 12, 2002
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: CPG 7909 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CPG 7909 Injection Drug: CPG 7909
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.
Other Name: PF-03512676


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  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. [ Time Frame: Indeterminate ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043407


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00043407    
Other Study ID Numbers: C010
CO10, A8501022
First Posted: August 12, 2002    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009
Keywords provided by Pfizer:
Renal Cell Carcinoma, Phase I, Phase II, Immunotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases