Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-08 @ 4:29 AM
Study NCT ID:
NCT00150995
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2005-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tetrathiomolybdate in Hormone Refractory Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020809', 'term': 'tetrathiomolybdate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': '12 weeks', 'description': 'To determine the time to progression of prostate cancer in patients with androgen-independent prostate cancer treated with tetrathiomolybdate. Disease progression is defined as at least a 20% increase in the sum of the longest diameter of the target lesions. For disease evaluable only by bone scan, the appearance of new lesions was considered evidence of progression. The development of pain in an existing lesion requiring institution of palliative radiotherapy or prescription narcotics was also considered evidence of progression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.', 'detailedDescription': "Tetrathiomolybdate or TM, a drug developed for Wilson's Disease, removes copper from the bloodstream. Copper is a key factor in angiogenesis (blood vessel growth)- a process that occurs normally in the body but becomes uncontrolled in cancerous cells. Tetrathiomolybdate essentially wages war against copper, which serves to choke off tumor growth. Realizing the key role of copper in angiogenesis, researchers have begun exploring treatment with Tetrathiomolybdate for different types of cancers. This clinical trial will evaluate the effectiveness of Tetrathiomolybdate in the treatment of patients with hormone refractory prostate cancer. Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responding to conventional hormonal treatment."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Patients must have histologic diagnosis of adenocarcinoma of the prostate with progression following hormonal therapy and antiandrogen withdrawal.\n* Patients must have minimal disease (defined as bone metastasis or visceral disease with no impairment of organ function or pain severe enough to require narcotics for control).\n* Adequate bone marrow and renal function\n* ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (a measure of general well being where 1 represents asymptomatic and 5 represents death)\n* Life expectancy of at least 16 weeks\n* Must have completed radiation more than 4 weeks prior to registration and must have a rising PSA (Prostate Specific Antigen) and lesion outside of the radiation field\n\nExclusion:\n\n* Patients with an elevated PSA as the only evidence of disease\n* Clinical evidence of spinal cord compression\n* History of prior malignancy within the past 5 years (with the exception of in situ carcinoma of any site or nonmelanoma skin cancer)'}, 'identificationModule': {'nctId': 'NCT00150995', 'briefTitle': 'Tetrathiomolybdate in Hormone Refractory Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'A Phase II Trail of Tetrathiomolybdate in Patients With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'UMCC 9962'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tetrathiomolybdate', 'description': 'Patients will be started on a dose of 60mg Tetrathiomolybdate at bedtime and 40mg 3 times per day.', 'interventionNames': ['Drug: Tetrathiomolybdate']}], 'interventions': [{'name': 'Tetrathiomolybdate', 'type': 'DRUG', 'armGroupLabels': ['Tetrathiomolybdate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'David C. Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Michigan Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}