Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00043420
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2002-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C483020', 'term': 'ProMune'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2002-08-08', 'studyFirstSubmitQcDate': '2002-08-09', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs', 'timeFrame': '24 weeks'}, {'measure': 'Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.', 'timeFrame': 'indeterminate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunotherapy, lymphoma'], 'conditions': ['Lymphoma, T-Cell, Cutaneous']}, 'referencesModule': {'references': [{'pmid': '32632956', 'type': 'DERIVED', 'citation': 'Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.'}, {'pmid': '20888065', 'type': 'DERIVED', 'citation': 'Kim YH, Girardi M, Duvic M, Kuzel T, Link BK, Pinter-Brown L, Rook AH. Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma. J Am Acad Dermatol. 2010 Dec;63(6):975-83. doi: 10.1016/j.jaad.2009.12.052.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CO14&StudyName=CPG%207909%20in%20Patients%20With%20Cutaneous%20T-Cell%20Lymphoma', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments.\n\nExclusion Criteria:\n\nPatients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) \\< 60 will be excluded.'}, 'identificationModule': {'nctId': 'NCT00043420', 'briefTitle': 'CPG 7909 in Patients With Cutaneous T-Cell Lymphoma', 'nctIdAliases': ['NCT00091208'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'C014'}, 'secondaryIdInfos': [{'id': 'CO14, A8501014'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I: 0.08 mg/kg', 'description': 'Escalating dose groups: 0.08 mg/kg PF-3512676 Injection', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: 0.16 mg/kg', 'description': 'Escalating dose groups: 0.16 mg/kg PF-3512676 Injection', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: 0.24 mg/kg', 'description': 'Escalating dose groups: 0.24 mg/kg PF-3512676 Injection', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: 0.28 mg/kg', 'description': 'Escalating dose groups: 0.28 mg/kg PF-3512676 Injection', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: 0.32 mg/kg', 'description': 'Escalating dose groups: 0.32 mg/kg PF-3512676 Injection', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: 0.36 mg/kg', 'description': 'Escalating dose groups: 0.36 mg/kg PF-3512676 Injection', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: 10 mg', 'description': 'Phase II: 10 mg flat dose (random assignment in Phase II)', 'interventionNames': ['Drug: PF-3512676']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: 25 mg', 'description': 'Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'interventionNames': ['Drug: PF-3512676']}], 'interventions': [{'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase I: 0.08 mg/kg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 0.16mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase I: 0.16 mg/kg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 0.24mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase I: 0.24 mg/kg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 0.28mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase I: 0.28 mg/kg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 0.32mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase I: 0.32 mg/kg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 0.36mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase I: 0.36 mg/kg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 10 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase II: 10 mg']}, {'name': 'PF-3512676', 'type': 'DRUG', 'otherNames': ['ProMune, CPG 7909'], 'description': 'Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.', 'armGroupLabels': ['Phase II: 25 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}