Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-28 @ 2:02 PM
Study NCT ID:
NCT00043368
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2002-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C483020', 'term': 'ProMune'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-11', 'studyFirstSubmitDate': '2002-08-08', 'studyFirstSubmitQcDate': '2002-08-09', 'lastUpdatePostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events and DLTs will be evaluated by the Investigator and summarized.', 'timeFrame': 'indeterminate'}], 'secondaryOutcomes': [{'measure': 'No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings.', 'timeFrame': 'indeterminate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CPG 7909 continuation study'], 'conditions': ['Melanoma', 'Breast Neoplasms', 'Carcinoma, Renal Cell', 'Lymphoma, T-Cell', 'Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C016&StudyName=PF-3512676%20%28CPG%207909%29%20Injection%20For%20Patients%20Who%20Completed%20An%20Oncology%20Study%20Using%20PF-3512676%20%28CPG%207909%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nImmediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy.\n\nExclusion Criteria:\n\nThe 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.'}, 'identificationModule': {'nctId': 'NCT00043368', 'briefTitle': 'PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'C016'}, 'secondaryIdInfos': [{'id': 'CO16, A8501015'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '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.', 'interventionNames': ['Drug: PF-3512676']}], 'interventions': [{'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['CPG 7909, ProMune'], 'description': '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.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkely', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site'}, {'zip': '95020', 'city': 'Gilroy', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.00578, 'lon': -121.56828}}, {'zip': '95023', 'city': 'Hollister', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 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