Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-01 @ 9:32 AM
Study NCT ID:
NCT00165295
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sildenafil Citrate in Waldenstrom's Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-23', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia."}]}, 'conditionsModule': {'keywords': ['sildenafil citrate', 'Viagra', "Waldenstrom's macroglobulinemia"], 'conditions': ["Waldenstrom's Macroglobulinemia"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.", 'detailedDescription': '* Sildenafil will be given orally (at home) at a reduced dose for the first week, then each week for 3 more weeks, the dose will be increased. If the patient has no major side effects, then they will receive the maximal dose for 2 years. If they have major side effects, then the dose of the drug might be lowered or the drug stopped.\n* Sildenafil will be continued until their is disease progression or serious side effects.\n* While patients are receiving sildenafil, they will be seen in the clinic on months 1,2,9,15 and 21 for blood tests and a subject questionnaire. They will also be seen on months 3,6,12,18 and 24 for a physical exam, blood test, physical assessment test, CT scans of chest, abdomen and pelvis, and a subject questionnaire.\n* At the end of the study (month 24) a physical exam, blood tests, physical assessment test and a questionnaire will be conducted.\n* Follow-up includes clinic visits at month 27,33,39 and 45 for blood tests and a questionnaire as well as visits at month 30,36,42 and 48 for physical exam, blood tests, physical assessment test, bone marrow aspirate and biopsy, CT scans of chest, abdomen and pelvis, and a questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia\n* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of \\> 2 times the upper limit of each institution's normal value\n* Slowly progressing disease not requiring therapy for at least 3-6 months\n* ECOG performance status 0,1 or 2\n* Total bilirubin \\< 2 x ULN\n* SGOT \\< 3 x ULN\n* Creatinine \\< 2 x ULN\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Patients who are using organic nitrates or alpha-blockers\n* Grade III/IV cardiac problems\n* Resting hypotension (BP \\< 90/50) or hypertension (BP \\> 170/110)\n* Cardiac failure or coronary artery disease causing unstable angina\n* Evidence of left ventricular outflow obstruction\n* Impaired autonomic control of blood pressure\n* Sickle cell anemia\n* History of priapism\n* Severe and/or uncontrolled medical disease\n* Known chronic liver disease\n* Currently using ritonavir\n* History of retinal pigmentosa"}, 'identificationModule': {'nctId': 'NCT00165295', 'briefTitle': "Sildenafil Citrate in Waldenstrom's Macroglobulinemia", 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': "Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia", 'orgStudyIdInfo': {'id': '05-087'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sildenafil citrate (Viagra)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven P. Treon, MD, MA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}]}}}