NCT00043368

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_2

Geographic Reach
2 countries

32 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 8, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

4.8 years

First QC Date

August 8, 2002

Last Update Submit

March 11, 2009

Conditions

Keywords

CPG 7909 continuation study

Outcome Measures

Primary Outcomes (1)

  • Adverse Events and DLTs will be evaluated by the Investigator and summarized.

    indeterminate

Secondary Outcomes (1)

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

    indeterminate

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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.

Also known as: CPG 7909, ProMune
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Pfizer Investigational Site

Berkely, California, 94704, United States

Location

Pfizer Investigational Site

Gilroy, California, 95020, United States

Location

Pfizer Investigational Site

Hollister, California, 95023, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90057, United States

Location

Pfizer Investigational Site

Los Angeles, California, 91342, United States

Location

Pfizer Investigational Site

Palm Springs, California, 92262, United States

Location

Pfizer Investigational Site

Stanford, California, 94305, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06504, United States

Location

Pfizer Investigational Site

Bonita Springs, Florida, 34135, United States

Location

Pfizer Investigational Site

Bradenton, Florida, 34209, United States

Location

Pfizer Investigational Site

Cape Coral, Florida, 33990, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, 33901, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, United States

Location

Pfizer Investigational Site

Naples, Florida, 34102, United States

Location

Pfizer Investigational Site

Plantation, Florida, 33324, United States

Location

Pfizer Investigational Site

Port Charlotte, Florida, 33980, United States

Location

Pfizer Investigational Site

Sarasota, Florida, 34232, United States

Location

Pfizer Investigational Site

Venice, Florida, 34285, United States

Location

Pfizer Investigational Site

Venice, Florida, 34292, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611-3124, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

Vincennes, Indiana, 47591, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Olive Branch, Mississippi, 38654, United States

Location

Pfizer Investigational Site

Oxford, Mississippi, 38655, United States

Location

Pfizer Investigational Site

Livingston, New Jersey, 07039, United States

Location

Pfizer Investigational Site

Asheville, North Carolina, 28801, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97213, United States

Location

Pfizer Investigational Site

Collierville, Tennessee, 38107, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38017, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38104, United States

Location

Pfizer Investigational Site

Cologne, 50931, Germany

Location

Related Links

MeSH Terms

Conditions

MelanomaBreast NeoplasmsCarcinoma, Renal CellLymphoma, T-CellCarcinoma, Non-Small-Cell Lung

Interventions

ProMune

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2002

First Posted

August 12, 2002

Study Start

September 1, 2002

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations