Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT00309894
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2006-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy
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': 'C081222', 'term': 'sargramostim'}, {'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2006-03-29', 'studyFirstSubmitQcDate': '2006-03-29', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression'}], 'secondaryOutcomes': [{'measure': 'Response rate as measured by prostate-specific antigen and objective parameters'}, {'measure': 'Frequency of grades 3-4 toxicity'}, {'measure': 'Pattern of immune response as measured by immunohistochemistry'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer.\n\nPURPOSE: This phase II trial is studying how well giving ketoconazole together with hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the effect of ketoconazole, hydrocortisone, and sargramostim (GM-CSF) on time to clinical progression in patients with prostate cancer that has progressed on primary hormonal therapy.\n\nSecondary\n\n* Evaluate the objective response frequency in patients treated with this regimen.\n* Investigate the safety of this regimen.\n\nOUTLINE: This is an open-label, nonrandomized study.\n\nPatients receive oral ketoconazole three times daily and oral hydrocortisone twice daily on days 1-28 and sargramostim (GM-CSF) subcutaneously on days 15-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Progressive disease after androgen deprivation AND meets 1 of the following criteria:\n\n * Measurable disease\n\n * Measurable lesions ≥ 10 mm with spiral CT\n * Up to 5 lesions per organ and 10 lesions total should be identified as target lesions\n * No measurable disease\n\n * Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA\n\n * PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart\n * Patients with a positive bone scan must also have an elevated PSA\n* Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen\n\n * Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue progression\n\n * Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation\n * Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation\n* Testosterone \\< 50 ng/dL\n* PSA ≥ 5 ng/mL\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* No serious intercurrent infections or nonmalignant uncontrolled medical illnesses\n* No psychiatric illnesses OR social situations that would limit compliance\n* No active or uncontrolled autoimmune disease\n* ALT and AST normal\n* Bilirubin normal\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Creatinine ≤ 1.5 times upper limit or normal (ULN)\n* Hemoglobin ≥ 8 g/dL\n* No other currently active malignancy except for nonmelanoma skin cancer\n\n * No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy\n* No prior systemic chemotherapy for prostate cancer\n\n * All other systemic chemotherapy must have been completed ≥ 2 years prior to study\n* No other concurrent chemotherapy, immunotherapy, or radiotherapy\n* Major surgery or radiation therapy completed ≥ 4 weeks prior to study\n* No other concurrent corticosteroids, including routine use antiemetics\n* No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer\n* No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)\n* Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels \\[e.g., saw palmetto or PC-SPES\\], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation\n* No initiation of bisphosphonate therapy within 1 month prior to starting study therapy\n\n * Patients on stable doses that show tumor progression are allowed to continue bisphosphonate\n* No concurrent supplements or complementary medicines/botanicals, except any combination of the following:\n\n * Conventional multivitamin supplements\n * Selenium\n * Lycopene\n * Soy supplements\n * Vitamin E\n* At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)\n* No other concurrent investigational or commercial anticancer agents or therapies'}, 'identificationModule': {'nctId': 'NCT00309894', 'briefTitle': 'Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation', 'orgStudyIdInfo': {'id': '035516'}, 'secondaryIdInfos': [{'id': 'UCSF-H45860-23833-02'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'sargramostim', 'type': 'BIOLOGICAL'}, {'name': 'ketoconazole', 'type': 'DRUG'}, {'name': 'therapeutic hydrocortisone', '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}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Francisco', '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'}}}}