Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT03116659
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTCL Directed Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': 'D004318', 'term': 'Doxycycline'}, {'id': 'D000077271', 'term': 'Imiquimod'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pilot assessment of response.', 'timeFrame': '1 year', 'description': 'Pilot assessment of response assessed by decreased size or surface change of the 5 lesions'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, T-Cell, Cutaneous']}, 'referencesModule': {'references': [{'pmid': '33851477', 'type': 'DERIVED', 'citation': 'Del Guzzo CA, Kojadinovic A, Vinnakota RR, Geskin LJ, Newman JC, Langhoff E, Park YA, Bates SE, Dana AN. Antibiotics and Imiquimod for Cutaneous T-Cell Lymphoma in Veterans: A Patient Population with Agent Orange Exposure. Oncologist. 2021 Sep;26(9):727-e1488. doi: 10.1002/onco.13785. Epub 2021 May 14.'}]}, 'descriptionModule': {'briefSummary': 'Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL is made by several years. Early skin lesions may look like any dermatitis, eczema, or psoriasis, leading to delays in the diagnosis.\n\nInflammation secondary to bacterial infection is thought to contribute to the T-cell proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes has shown to reduce the inflammation and size of lesions in CTCL patients. There has been limited studies with the use of antibiotics as direct treatment for this cancer.\n\nHost immunity is important in decreasing cancer development and progression. Imiquimod is a molecule that stimulates host immunity to reduce the progression of CTCL. There is strong evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN) guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it unlikely to be registered specifically for CTCL, despite its efficacy.\n\nAdditionally, imiquimod is considered a first line treatment according to National Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.\n\nThere are currently no studies that have been published that address treating CTCL patients with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics, and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat patient with 14days of antibiotics and 30 days of Imiquimod there will be significant reduction in skin lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 30 - 89 years old\n* Stages I to II CTCL patients\n* Normal renal function, Cr ≤ 1.5\n\nExclusion Criteria:\n\n* Aggressively progressing CTCL\n* Active infection and/or concurrent malignancy\n* Poor renal function (Cr \\> 1.5)\n* Pregnancy (HCG serum +)\n* History of bone marrow suppression, MDS, anemia (Hemoglobin \\< 8), thrombocytopenia (\\< 50,000) or neutropenia (ANC \\< 1500)\n* CHF, MI within last 6 months\n* Endocarditis\n* Allergies to Imiquimod or doxycycline'}, 'identificationModule': {'nctId': 'NCT03116659', 'briefTitle': 'CTCL Directed Therapy', 'organization': {'class': 'FED', 'fullName': 'James J. Peters Veterans Affairs Medical Center'}, 'officialTitle': 'CTCL Directed Therapy', 'orgStudyIdInfo': {'id': 'DAN-15-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days', 'interventionNames': ['Drug: Doxycycline', 'Drug: Imiquimod']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'description': 'Doxycycline 100 mg PO BID x 14 days', 'armGroupLabels': ['Single Arm']}, {'name': 'Imiquimod', 'type': 'DRUG', 'description': 'up to 2 packs 3/ week x 28 days', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ali Dana, MD/PhD', 'role': 'CONTACT'}], 'facility': 'James J Peters Bronx Veterans Affairs Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Ali Dana, MD', 'role': 'CONTACT', 'email': 'Ali.Dana@VA.gov', 'phone': '718-584-9000', 'phoneExt': '5289'}], 'overallOfficials': [{'name': 'Ali Dana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James J. Peters VAMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'James J. Peters Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist', 'investigatorFullName': 'Ali Dana', 'investigatorAffiliation': 'James J. Peters Veterans Affairs Medical Center'}}}}