Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT00005069
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide 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': 'D000077237', 'term': 'Arsenic Trioxide'}], 'ancestors': [{'id': 'D001152', 'term': 'Arsenicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2001-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2000-04-06', 'studyFirstSubmitQcDate': '2004-05-25', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV renal cell cancer', 'recurrent renal cell cancer'], 'conditions': ['Kidney 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 arsenic trioxide in treating patients who have metastatic kidney cancer.', 'detailedDescription': 'OBJECTIVES: I. Evaluate the efficacy of arsenic trioxide in patients with metastatic renal cell cancer. II. Determine the safety of this regimen in this patient population.\n\nOUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for 5 days. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 1 month.\n\nPROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer Bidimensionally measurable disease No brain metastases\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal ALT or AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN (no greater than 1.95 mg/dL at MSKCC) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study No other prior malignancy unless curatively treated and disease free for the past 5 years and considered low risk for recurrence\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery'}, 'identificationModule': {'nctId': 'NCT00005069', 'briefTitle': 'Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '99-107'}, 'secondaryIdInfos': [{'id': 'CDR0000067674', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-T99-0105'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'arsenic trioxide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert J. Motzer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}