Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00003802
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C064541', 'term': 'NSC 366140'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-12', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-05-01', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['iris melanoma', 'ciliary body and choroid melanoma, small size', 'ciliary body and choroid melanoma, medium/large size', 'extraocular extension melanoma', 'recurrent intraocular melanoma', 'stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Intraocular Melanoma', 'Melanoma (Skin)']}, '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 pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma.\n* Determine the toxic effects of PZA in this patient population.\n* Determine the pharmacokinetic profile of PZA in these patients.\n\nOUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.\n\nPatients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: Approximately 28-70 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive\n* Bidimensionally measurable disease\n* No pleural effusions or ascites\n* No untreated CNS metastases\n* Stable brain metastases by CT or MRI scan\n\n * At least 4 weeks since prior steroid therapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* WBC at least 4,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No active infection\n* No known hypersensitivity to E.coli derived proteins\n* No other serious medical problems\n* No more than 1 primary malignancy within past 5 years, other than:\n\n * Nonmelanomatous skin cancer\n * Carcinoma in situ of the cervix\n* No history of spinal cord compression\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed\n* No other prior radiotherapy\n\nSurgery:\n\n* At least 2 weeks since prior surgery and recovered'}, 'identificationModule': {'nctId': 'NCT00003802', 'briefTitle': 'Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma', 'orgStudyIdInfo': {'id': 'JHOC-J9875, CDR0000066946'}, 'secondaryIdInfos': [{'id': 'U01CA063437', 'link': 'https://reporter.nih.gov/quickSearch/U01CA063437', 'type': 'NIH'}, {'id': 'P30CA006973', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006973', 'type': 'NIH'}, {'id': 'JHOC-98111005'}, {'id': 'JHOC-JH9875'}, {'id': 'JHOC-T96-0116'}, {'id': 'NCI-T96-0116'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'pyrazoloacridine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'William H. Sharfman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}