Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00305669
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2006-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GM-CSF Before Surgery in Treating Patients With Localized 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': 'C081222', 'term': 'sargramostim'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2006-03-21', 'studyFirstSubmitQcDate': '2006-03-21', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.', 'timeFrame': 'up to 6 weeks following surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective treatment for localized prostate cancer.\n\nPURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in treating patients with localized prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.\n* Determine whether tissue-specific antiprostate cancer immunity is induced by the administration of neoadjuvant GM-CSF in patients with localized prostate cancer prior to radical prostatectomy.\n\nSecondary\n\n* Estimate the baseline antitumor immune response in patients treated with 2 different dose schedules of GM-CSF.\n* Determine the magnitude of the difference in immune response between 2 dose schedules of GM-CSF.\n* Determine the clinical effects, including prostate-specific antigen (PSA) decline, surgical outcome, surgical complications, and histologic appearance of surgical specimen, of this regimen in these patients.\n\nOUTLINE: This is a pilot study. Patients are stratified according to sargramostim (GM-CSF) dose.\n\nPatients receive 1 of 2 dose levels of GM-CSF subcutaneously on days 1-14 or 1-21. Treatment continues in the absence of unacceptable toxicity. Within 3 days after the last dose of GM-CSF, patients undergo radical prostatectomy.\n\nBlood is collected at baseline, day 28 of each course, and at the 4-week follow-up visit and is examined for activated T-cells. Tissue is collected during surgery and assessed for biomarkers and cytokines.\n\nAfter completion of study treatment, patients are followed at 4 weeks.\n\nPROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n\n * No neuroendocrine or small cell features\n* No evidence of metastatic disease\n* Planning radical prostatectomy at least 2 months from now\n* Testosterone level normal\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 8 g/dL\n* AST and ALT ≤ 1.5 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 times ULN\n* Creatinine ≤ 1.5 times ULN\n* PT and PTT normal\n* Fertile patients must use effective barrier contraception\n* No history of allergic reaction to compounds of similar chemical or biologic composition to sargramostim (GM-CSF)\n* No ongoing or active bacterial, viral, or fungal infection\n* DLCO \\> 50% if patient has a history of clinically significant obstructive airway disease\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No other active malignancy, defined as cancer for which therapy has been completed and patient is now considered \\< 30% risk of relapse, except nonmelanoma skin cancer\n* No psychiatric illness or social situation that would preclude study compliance\n* No other uncontrolled illness\n* No underlying medical condition that, in the opinion of the principal investigator, may make the administration of GM-CSF hazardous or obscure the interpretation of adverse events\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 4 weeks since prior major surgery\n* No prior radiotherapy, immunotherapy, chemotherapy, or other investigational therapy for this cancer\n* No prior hormonal therapy including any of the following:\n\n * Luteinizing-hormone releasing hormone (LHRH) agonists\n * LHRH antagonists\n * Antiandrogens, including any of the following:\n\n * Bilcalutamide\n * Flutamide\n * Nilutamide\n * 5-alpha-reductase inhibitors\n * PC-SPES or other PC-x product\n * Estrogen-containing nutriceuticals\n* No concurrent chemotherapy or radiotherapy\n* No concurrent systemic steroid therapy\n\n * Concurrent inhaled or topical steroids allowed\n* No other concurrent immunotherapy\n* No other concurrent investigational agent\n* No other concurrent anticancer agents or therapies'}, 'identificationModule': {'nctId': 'NCT00305669', 'briefTitle': 'GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Pilot Study of Two Dose Schedules of Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000455649'}, 'secondaryIdInfos': [{'id': 'UCSF-04558'}, {'id': 'UCSF-H40568-25161-02B'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GM-CSF before surgery', 'description': 'GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks', 'interventionNames': ['Biological: sargramostim', 'Other: immunohistochemistry staining method', 'Other: immunological diagnostic method', 'Other: laboratory biomarker analysis', 'Procedure: conventional surgery', 'Procedure: neoadjuvant therapy']}], 'interventions': [{'name': 'sargramostim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['GM-CSF before surgery']}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'armGroupLabels': ['GM-CSF before surgery']}, {'name': 'immunological diagnostic method', 'type': 'OTHER', 'armGroupLabels': ['GM-CSF before surgery']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['GM-CSF before surgery']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['GM-CSF before surgery']}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['GM-CSF before surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Lawrence Fong, 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'}}}}