Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 3:22 PM
Study NCT ID:
NCT00001059
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012514', 'term': 'Sarcoma, Kaposi'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D008081', 'term': 'Liposomes'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008567', 'term': 'Membranes, Artificial'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D004337', 'term': 'Drug Carriers'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D040761', 'term': 'Biomimetic Materials'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '1998-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-13', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Vincristine', 'Sarcoma, Kaposi', 'Liposomes', 'Doxorubicin', 'Drug Therapy, Combination', 'Granulocyte Colony-Stimulating Factor', 'Acquired Immunodeficiency Syndrome', 'Bleomycin', 'Drug Carriers'], 'conditions': ['Sarcoma, Kaposi', 'HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Mitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191"}]}, 'descriptionModule': {'briefSummary': "To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life.\n\nLiposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.", 'detailedDescription': 'Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.\n\nPatients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia.\n\nAS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* G-CSF.\n* Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).\n* PCP prophylaxis (required if CD4 count \\< 200 cells/mm3).\n* Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.\n* Up to 14 days of metronidazole.\n* Recombinant erythropoietin.\n\nPatients must have:\n\n* Documented HIV infection.\n* Advanced stage Kaposi's sarcoma.\n* No active acute opportunistic infection.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Significant pulmonary insufficiency (unless due to pulmonary KS).\n* Significant cardiac insufficiency.\n* Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.\n* Grade 2 or worse peripheral neuropathy.\n* Altered mental status that prevents informed consent.\n* Active Mycobacterium tuberculosis.\n* Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).\n\nConcurrent Medication:\n\nExcluded:\n\n* GM-CSF.\n* Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).\n* Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy to study marker lesions.\n\nPatients with the following prior condition are excluded:\n\n* Neuropsychiatric history.\n\nPrior Medication:\n\nExcluded:\n\n* Any anti-KS therapy within 21 days prior to study entry.\n* Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.\n* Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.\n\nPER AMENDMENT 11/29/95:\n\n* No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma."}, 'identificationModule': {'nctId': 'NCT00001059', 'briefTitle': "Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS", 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': "Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma", 'orgStudyIdInfo': {'id': 'ACTG 286'}, 'secondaryIdInfos': [{'id': '11262', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Doxorubicin hydrochloride (liposomal)', 'type': 'DRUG'}, {'name': 'Filgrastim', 'type': 'DRUG'}, {'name': 'Bleomycin sulfate', 'type': 'DRUG'}, {'name': 'Vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Therapeutics CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Aids Crs', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Miami AIDS CRS', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Queens Med. Ctr.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96816', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Univ. of Hawaii at Manoa, Leahi Hosp.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Univ. Med. Ctr. ACTG CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ. School of Medicine, Infectious Disease Research Clinic', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bmc Actg Crs', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess - East Campus A0102 CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital ACTG CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington U CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY - Buffalo, Erie County Medical Ctr.', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Ctr.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mitsuyasu R', 'role': 'STUDY_CHAIR'}, {'name': 'Krown S', 'role': 'STUDY_CHAIR'}, {'name': 'Von Roenn JH', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Sequus Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}