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

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NCT00043368

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Study Location
Pfizer Investigational Site
Berkely, California, 94704, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma, Breast Neoplasms, Renal Cell Carcinoma, T-Cell Lymphoma, Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Melanoma, Breast Neoplasms, Renal Cell Carcinoma, T-Cell Lymphoma, Non-Small-Cell Lung CarcinomaPF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
NCT00043368
  1. Berkely, California
  2. Gilroy, California
  3. Hollister, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Palm Springs, California
  7. Stanford, California
  8. New Haven, Connecticut
  9. Bonita Springs, Florida
  10. Bradenton, Florida
  11. Cape Coral, Florida
  12. Fort Myers, Florida
  13. Fort Myers, Florida
  14. Naples, Florida
  15. Plantation, Florida
  16. Port Charlotte, Florida
  17. Sarasota, Florida
  18. Venice, Florida
  19. Venice, Florida
  20. Chicago, Illinois
  21. Chicago, Illinois
  22. Vincennes, Indiana
  23. Ann Arbor, Michigan
  24. Olive Branch, Mississippi
  25. Oxford, Mississippi
  26. Livingston, New Jersey
  27. Asheville, North Carolina
  28. Portland, Oregon
  29. Collierville, Tennessee
  30. Memphis, Tennessee
  31. Memphis, Tennessee
  32. Koeln,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Lymphoma, T-Cell
  • Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE 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 Name: CPG 7909, ProMune
Study Arms  ICMJE 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.
Intervention: Drug: PF-3512676
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2009)		31
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		50
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00043368
Other Study ID Numbers  ICMJE C016
CO16, A8501015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP