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| 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: | 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 |
| 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 |
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
Show 32 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| 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 |
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CPG 7909 continuation study |
|
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 |
