PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00043368
First received: August 8, 2002
Last updated: March 11, 2009
Last verified: March 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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 |
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 |
|---|---|
|
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 Name: CPG 7909, ProMune
|
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
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| United States, California | |
| Pfizer Investigational Site | |
| 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, 91342 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90057 | |
| Pfizer Investigational Site | |
| Palm Springs, California, United States, 92262 | |
| Pfizer Investigational Site | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06504 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Fort Myers, Florida, United States, 33901 | |
| 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 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611-3124 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Vincennes, Indiana, United States, 47591 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Olive Branch, Mississippi, United States, 38654 | |
| Pfizer Investigational Site | |
| Oxford, Mississippi, United States, 38655 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Livingston, New Jersey, United States, 07039 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97213 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Collierville, Tennessee, United States, 38107 | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38017 | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38104 | |
| Germany | |
| Pfizer Investigational Site | |
| Koeln, Germany, 50931 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00043368 History of Changes |
| Other Study ID Numbers: | C016, CO16, A8501015 |
| Study First Received: | August 8, 2002 |
| Last Updated: | March 11, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
CPG 7909 continuation study |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Lymphoma Melanoma Lymphoma, T-Cell Neoplasms by Site Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013