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

March 11, 2009 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Koeln, Germany, 50931
        • Pfizer Investigational Site
  • United States
    • California
      • Berkely, California, United States, 94704
        • Pfizer Investigational Site
      • Gilroy, California, United States, 95020
        • Pfizer Investigational Site
      • Hollister, California, United States, 95023
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90057
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 91342
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262
        • Pfizer Investigational Site
      • Stanford, California, United States, 94305
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Pfizer Investigational Site
    • Florida
      • Bonita Springs, Florida, United States, 34135
        • Pfizer Investigational Site
      • Bradenton, Florida, United States, 34209
        • Pfizer Investigational Site
      • Cape Coral, Florida, United States, 33990
        • Pfizer Investigational Site
      • Fort Myers, Florida, United States, 33901
        • Pfizer Investigational Site
      • Fort Myers, Florida, United States
        • Pfizer Investigational Site
      • Naples, Florida, United States, 34102
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • Port Charlotte, Florida, United States, 33980
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34232
        • Pfizer Investigational Site
      • Venice, Florida, United States, 34285
        • Pfizer Investigational Site
      • Venice, Florida, United States, 34292
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60611-3124
        • Pfizer Investigational Site
    • Indiana
      • Vincennes, Indiana, United States, 47591
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
      • Oxford, Mississippi, United States, 38655
        • Pfizer Investigational Site
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Pfizer Investigational Site
    • Tennessee
      • Collierville, Tennessee, United States, 38107
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38017
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events and DLTs will be evaluated by the Investigator and summarized.
Time Frame: indeterminate
indeterminate

Secondary Outcome Measures

Outcome Measure
Time Frame
No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings.
Time Frame: indeterminate
indeterminate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

August 8, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (ESTIMATE)

August 12, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C016
  • CO16, A8501015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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