Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-30 @ 7:21 PM
Study NCT ID:
NCT00003968
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046785', 'term': 'bryostatin 1'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-01', 'lastUpdateSubmitDate': '2013-02-07', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-30', 'lastUpdatePostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV renal cell cancer', 'recurrent renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.', 'detailedDescription': 'OBJECTIVES:\n\nI. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.\n\nII. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.\n\nIV. Determine the overall survival of this patient population treated with this regimen.\n\nOUTLINE:\n\nPatients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic renal cell carcinoma\n* Bidimensionally measurable disease\n* Clear evidence of progression if only site of measurable disease is within previous radiation port\n* Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids\n\nPATIENT CHARACTERISTICS:\n\n* Age: 18 and over\n* Performance status: ECOG 0-1\n* Life expectancy: Greater than 3 months\n* WBC at least 3,000/mm3\n* Platelet count at least 100,00/mm3\n* Bilirubin no greater than 1.5 mg/dL\n* Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study\n* No active bacterial or viral infection\n* No serious underlying medical condition that would interfere with compliance\n* No other malignancy within the past 5 years except basal cell carcinoma of the skin\n* No dementia or altered mental status that would prevent informed consent\n\nPRIOR CONCURRENT THERAPY:\n\n* No more than 1 prior therapy with biologic response modifiers\n* No prior chemotherapy for advanced disease\n* No other concurrent chemotherapy\n* No concurrent steriods (except topical use)\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n* At least 4 weeks since major surgery (including nephrectomy)\n* No other concurrent experimental agents'}, 'identificationModule': {'nctId': 'NCT00003968', 'briefTitle': 'Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)', 'orgStudyIdInfo': {'id': 'NCI-2012-02303'}, 'secondaryIdInfos': [{'id': 'FCCC-99012'}, {'id': 'NCI-T99-0002'}, {'id': 'CDR0000067169', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.', 'interventionNames': ['Drug: bryostatin 1']}], 'interventions': [{'name': 'bryostatin 1', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hunterdon Regional Cancer Center', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '08701', 'city': 'Lakewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kimball Medical Center', 'geoPoint': {'lat': 40.09789, 'lon': -74.21764}}, {'zip': '08332', 'city': 'Millville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Hospital - Millville', 'geoPoint': {'lat': 39.40206, 'lon': -75.03934}}, {'zip': '08060', 'city': 'Mount Holly', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County', 'geoPoint': {'lat': 39.99289, 'lon': -74.78766}}, {'zip': '07701', 'city': 'Red Bank', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Riverview Medical Center', 'geoPoint': {'lat': 40.34705, 'lon': -74.06431}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '08629', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'St. Francis Medical Center', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bon Secours-Holy Family Health System', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '19026', 'city': 'Drexel Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Delaware County Memorial Hospital', 'geoPoint': {'lat': 39.94706, 'lon': -75.29213}}, {'zip': '17105-8700', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Hospitals', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '15905', 'city': 'Johnstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Conemaugh Memorial Hospital', 'geoPoint': {'lat': 40.32674, 'lon': -78.92197}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Saint Mary Medical Center', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'North Penn Hospital', 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '19301-1792', 'city': 'Paoli', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paoli Memorial Hospital', 'geoPoint': {'lat': 40.04205, 'lon': -75.47631}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19464', 'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pottstown Memorial Regional Cancer Center', 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'zip': '19612-6052', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}], 'overallOfficials': [{'name': 'Naomi S. Balzer-Haas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}