Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 11:48 PM
Study NCT ID:
NCT00043212
Status:
WITHDRAWN
Last Update Posted:
2013-05-01
First Post:
2002-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Redirection of company goals', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-30', 'studyFirstSubmitDate': '2002-08-06', 'studyFirstSubmitQcDate': '2002-08-07', 'lastUpdatePostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['prostate cancer', 'oncology', 'urology', 'hormone refractory prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nwbio.com', 'label': 'Northwest Biotherapeutics, Inc.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.', 'detailedDescription': 'Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient\'s own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain \\& swelling at the injection site, and short-lived headache, fever \\& fatigue. Full details are available in the informed consent.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Hormone refractory prostate cancer (HRPC) \\– progressive disease despite androgen deprivation and serum testosterone \\<50ng/dL; progression defined as either:\n\n 1. Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement \\>2.0 ng/ml; or\n 2. Progression of metastatic lesion on bone scan, or\n 3. Progression of lymph node metastasis by CT scan.\n* Zubrod or ECOG performance status of 0-1.\n* Three or fewer bone metastases on a bone scan with minimal symptoms.\n* No lymph node lesions greater than 3.0 cm at longest diameter.\n* Adequate hematological, hepatic and renal function.\n\nExclusion Criteria\n\n* History of other active malignancy.\n* Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months.\n* Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment.\n* Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness.\n* Prior splenectomy.\n* History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test.\n* History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke.\n* History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.\n* Impending untreated spinal cord compression or urinary outlet obstruction.\n* Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).'}, 'identificationModule': {'nctId': 'NCT00043212', 'briefTitle': 'Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Northwest Biotherapeutics'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'DC3-HRPC, October 2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dendritic cell immunotherapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Centers of Florida, P.A.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Solutions', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Regional Cancer Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas HealthCare System', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwest Biotherapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}