Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT00313534
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2006-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed 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': 'D009637', 'term': 'Masoprocol'}], 'ancestors': [{'id': 'D017705', 'term': 'Lignans'}, {'id': 'D001593', 'term': 'Benzyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Ran out of drug', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-09', 'studyFirstSubmitDate': '2006-04-11', 'studyFirstSubmitQcDate': '2006-04-11', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity as measured by CTC v3.0'}], 'secondaryOutcomes': [{'measure': 'Maximum tolerated dose'}, {'measure': 'Prostate-specific antigen (PSA) at baseline and on day 1 of each course'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer', 'stage I prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.\n\nSecondary\n\n* Determine prostate-specific antigen-modulating effects of NDGA in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed prostate cancer, meeting 1 of the following criteria:\n\n * Androgen-dependent disease (testosterone ≥ 250 ng/mL)\n * Androgen-independent disease (testosterone \\< 50 ng/mL)\n* Received prior definitive therapy for primary prostate cancer comprising any of the following:\n\n * External-beam radiotherapy with or without hormonal therapy\n * Brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy\n * Radical prostatectomy with or without adjuvant or salvage radiotherapy\n * Cryotherapy\n* Must have evidence of disease progression, as evidenced by elevated prostate-specific antigen (PSA) that has risen serially from post-definitive therapy nadir on 2 determinations taken ≥ 1 week apart\n\n * Elevated PSA, meeting 1 of the following criteria:\n\n * At least 1.0 ng/mL post radiotherapy or cryotherapy\n * At least 4 ng/mL post radical prostatectomy\n * Must show disease progression after discontinuation of the antiandrogen (for patients with androgen-dependent disease receiving antiandrogen as part of primary androgen ablation)\n* No metastatic disease, confirmed by negative bone scan and negative CT scan or MRI of abdomen/pelvis\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 70-100%\n* Absolute neutrophil count ≥ 1,500/mm³\n* Hemoglobin ≥ 8.0 g/dL\n* Platelet count ≥ 100,000/mm³\n* Creatinine ≤ 1.5 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 times ULN\n* AST ≤ 1.5 times ULN\n* No other medical condition that would interfere with study therapy or compliance\n* No other active malignancy except previously treated squamous cell or basal cell skin cancer or cancer that has been treated and considered to be at \\< 30% risk of relapse\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 8 weeks since prior strontium-chloride Sr 89\n* More than 4 weeks since first dose of bisphosphonates\n* More than 4 weeks since prior major surgery or radiotherapy\n* At least 4 weeks since prior hormonal agents, including megestrol or steroids\n\n * Concurrent luteinizing hormone-releasing hormone analogs allowed to maintain castrate levels of testosterone\n* At least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any herbal agent intended to lower PSA\n* Prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for androgen-dependent prostate cancer provided that all of the following are met:\n\n * No more than 8 months of androgen deprivation\n * At least 12 months since last day of effective androgen deprivation\n * Testosterone \\> 250 ng/mL at enrollment\n* Prior hormonal therapy, chemotherapy, or investigational therapy for biochemical relapse allowed\n* No concurrent chemotherapeutic, immunotherapeutic, or other investigational agents\n* No concurrent radiotherapy\n* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)'}, 'identificationModule': {'nctId': 'NCT00313534', 'briefTitle': 'Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000455645'}, 'secondaryIdInfos': [{'id': 'UCSF-035510'}, {'id': 'UCSF-H45860-23712-02A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'masoprocol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Charles Ryan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}