Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00003205
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046785', 'term': 'bryostatin 1'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-12', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-04-22', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with stage IV breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the clinical response of patients with stage IV breast cancer to bryostatin 1.\n* Determine the efficacy of this regimen in these patients.\n* Estimate the pharmacokinetic parameters of bryostatin 1 when given as 24 hour infusion.\n* Determine the ability of this regimen to regulate lymphocyte function in these patients.\n* Determine the effect of this regimen on platelet function and protein kinase C activity in these patients.\n\nOUTLINE: Patients receive bryostatin 1 IV over 24 hours. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 4-8 weeks for tumor response.\n\nPROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Unequivocal diagnosis of metastatic breast cancer\n* Bidimensionally measurable disease\n* No uncontrolled CNS metastases\n* No disease that is evaluable only, including blastic bone disease, malignant ascites, and malignant pleural effusion\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* SWOG 0-2 OR\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* At least 18 weeks\n\nHematopoietic:\n\n* Platelet count at least 50,000/mm\\^3\n* PT and PTT within normal limits\n* Neutrophil count at least 2,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.2 mg/dL\n* Transaminases no greater than 3 times normal\n\nRenal:\n\n* Creatinine no greater than 1.6 mg/dL OR\n* Creatinine clearance at least 70 mL/min\n\nOther:\n\n* No active infections requiring antibiotics\n* No viral hepatitis allowed\n* Seronegative for hepatitis B or C\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 2 months following study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* 2 prior chemotherapy regimens for metastatic disease allowed as adjuvant therapy or for advanced disease (may include high dose chemotherapy with stem cell support)\n* At least 4 weeks since prior chemotherapy\n* At least 6 weeks since prior nitrosourea or mitomycin therapy\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* 2 prior hormonal therapy regimens for metastatic disease as adjuvant therapy or for advanced diseases allowed\n* At least 2 weeks since prior hormonal therapy (at least 4 weeks in case of disease progression while receiving hormonal therapy after initial response)\n* No concurrent hormonal therapy except oral contraceptives\n* No concurrent use of steroids except for management of severe or life- threatening toxic effects arising from bryostatin 1\n\nRadiotherapy:\n\n* At least 2 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent use of drugs known to interfere with platelet function, such as aspirin or NSAIDs (including ibuprofen)\n* No concurrent use of anticoagulants\n* At least 2 weeks since prior use of aspirin\n* At least 2 days since prior use of NSAIDS\n* Concurrent use of acetaminophen to control pain is allowed\n* If acetaminophen inadequate for pain control, concurrent use of oral narcotics such as codeine or oxycodone is allowed'}, 'identificationModule': {'nctId': 'NCT00003205', 'briefTitle': 'Bryostatin 1 in Treating Patients With Stage IV Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer', 'orgStudyIdInfo': {'id': '97-0751.cc'}, 'secondaryIdInfos': [{'id': 'UCHSC-97751'}, {'id': 'NCI-T97-0063'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bryostatin 1', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80010', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Andrew S. Kraft, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}