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PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
This study has been completed.
First Received: August 8, 2002   Last Updated: March 11, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00043368
  Purpose

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


Condition Intervention Phase
Melanoma
Breast Neoplasms
Carcinoma, Renal Cell
Lymphoma, T-Cell
Carcinoma, Non-Small-Cell Lung
Drug: PF-3512676
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse Events and DLTs will be evaluated by the Investigator and summarized. [ Time Frame: indeterminate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings. [ Time Frame: indeterminate ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: September 2002
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043368

  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: C016, CO16, A8501015
Study First Received: August 8, 2002
Last Updated: March 11, 2009
ClinicalTrials.gov Identifier: NCT00043368     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
CPG 7909 continuation study

Additional relevant MeSH terms:
Thoracic Neoplasms
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Urologic Neoplasms
Melanoma
Neoplasms by Site
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Lymphoma, T-Cell
Nevi and Melanomas
Kidney Diseases
Lymphoma
Breast Diseases
Respiratory Tract Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Skin Diseases
Breast Neoplasms
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Lymphatic Diseases
Neoplasms
Lung Diseases
Carcinoma, Renal Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on November 22, 2009