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PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00043368
Collaborator
(none)
31
Enrollment
32
Locations
1
Arm
57
Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Continuation Study Of PF-3512676 (CPG 7909) Injection In Patients With Metastatic Or Recurrent Malignancies Who Have Stable Disease Or Who Have Responded To Pf-3512676 Injection Therapy
Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Patients will be treated with the same dosing regimen and schedule of PF-3512676 Injection with which they were treated at the end of the previous PF-3512676 Injection trial. Any proposed changes to their schedule/regimen will be at the discretion of the treating physician, following consultation with Coley.

Drug: PF-3512676
PF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg.
Other Names:
  • CPG 7909, ProMune

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events and DLTs will be evaluated by the Investigator and summarized. [indeterminate]

    Secondary Outcome Measures

    1. No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings. [indeterminate]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Immediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy.

    Exclusion Criteria:

    The patient has received any anti-neoplastic therapy since completing a prior trial with PF-3512676 Injection, or has participated in another clinical trial following participation in a trial with PF-3512676 Injection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Berkely California United States 94704
    2 Pfizer Investigational Site Gilroy California United States 95020
    3 Pfizer Investigational Site Hollister California United States 95023
    4 Pfizer Investigational Site Los Angeles California United States 90057
    5 Pfizer Investigational Site Los Angeles California United States 91342
    6 Pfizer Investigational Site Palm Springs California United States 92262
    7 Pfizer Investigational Site Stanford California United States 94305
    8 Pfizer Investigational Site New Haven Connecticut United States 06504
    9 Pfizer Investigational Site Bonita Springs Florida United States 34135
    10 Pfizer Investigational Site Bradenton Florida United States 34209
    11 Pfizer Investigational Site Cape Coral Florida United States 33990
    12 Pfizer Investigational Site Fort Myers Florida United States 33901
    13 Pfizer Investigational Site Fort Myers Florida United States
    14 Pfizer Investigational Site Naples Florida United States 34102
    15 Pfizer Investigational Site Plantation Florida United States 33324
    16 Pfizer Investigational Site Port Charlotte Florida United States 33980
    17 Pfizer Investigational Site Sarasota Florida United States 34232
    18 Pfizer Investigational Site Venice Florida United States 34285
    19 Pfizer Investigational Site Venice Florida United States 34292
    20 Pfizer Investigational Site Chicago Illinois United States 60611-3124
    21 Pfizer Investigational Site Chicago Illinois United States 60611
    22 Pfizer Investigational Site Vincennes Indiana United States 47591
    23 Pfizer Investigational Site Ann Arbor Michigan United States 48109
    24 Pfizer Investigational Site Olive Branch Mississippi United States 38654
    25 Pfizer Investigational Site Oxford Mississippi United States 38655
    26 Pfizer Investigational Site Livingston New Jersey United States 07039
    27 Pfizer Investigational Site Asheville North Carolina United States 28801
    28 Pfizer Investigational Site Portland Oregon United States 97213
    29 Pfizer Investigational Site Collierville Tennessee United States 38107
    30 Pfizer Investigational Site Memphis Tennessee United States 38017
    31 Pfizer Investigational Site Memphis Tennessee United States 38104
    32 Pfizer Investigational Site Koeln Germany 50931

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00043368
    Other Study ID Numbers:
    • C016
    • CO16, A8501015
    First Posted:
    Aug 12, 2002
    Last Update Posted:
    Mar 12, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    CPG 7909 continuation study
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Carcinoma, Renal Cell
    Lymphoma, T-Cell

    Study Results

    No Results Posted as of Mar 12, 2009