Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00349167
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2006-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PR-104 in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522381', 'term': 'PR-104'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2006-07-05', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '20012293', 'type': 'RESULT', 'citation': 'Jameson MB, Rischin D, Pegram M, Gutheil J, Patterson AV, Denny WA, Wilson WR. A phase I trial of PR-104, a nitrogen mustard prodrug activated by both hypoxia and aldo-keto reductase 1C3, in patients with solid tumors. Cancer Chemother Pharmacol. 2010 Mar;65(4):791-801. doi: 10.1007/s00280-009-1188-1. Epub 2009 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors.\n* Determine the maximum tolerated dose of PR-104 in these patients.\n\nSecondary\n\n* Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these patients.\n* Assess evidence of antitumor activity of this drug in these patients.\n\nTertiary\n\n* Examine metabolic changes in tumors of these patients using fludeoxyglucose F 18 positron emission tomography scanning.\n\nOUTLINE: This is a multicenter, open-label, prospective, uncontrolled, dose-escalation study.\n\nPatients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of PR-104 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nBlood is collected at baseline and then periodically during study treatment for pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron emission tomography scanning before beginning study treatment and after completion of course 2 to assess metabolic activity of the tumor.\n\nAfter completion of study treatment, patients are followed at 30 days.\n\nPROJECTED ACCRUAL: A total of 30 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 or cytologically confirmed solid tumor, meeting 1 of the following criteria:\n\n * Not amenable to standard therapy\n * Refractory to conventional therapy\n* Measurable or evaluable disease\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 70-100%\n* Life expectancy \\> 3 months\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin \\> 9 g/L (transfusion independent)\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* ALT and AST ≤ 2.5 times ULN\n* Creatinine clearance ≥ 60 mL/min\n* PT/INR or aPTT ≤ 1.1 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 30 days after completion of study treatment\n* No significant cardiac comorbidity including any of the following:\n\n * New York Heart Association class III-IV congenital heart failure\n * LVEF \\< 40%\n * Unstable angina\n * Myocardial infarction within the past 6 months\n * Ventricular arrhythmias requiring drug therapy\n * Pacemaker or implanted defibrillator\n* No ongoing coagulopathy\n* No uncontrolled infection or infection requiring parenteral antibiotics\n* No other significant clinical disorder or laboratory finding that would preclude study treatment\n* No known HIV positivity\n* No known positivity for hepatitis B surface antigen or hepatitis C with abnormal liver tests\n* No known allergy to nonplatinum-containing alkylating agents\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from prior therapy\n* More than 2 weeks since prior hormonal therapy (except for androgen-deprivation therapy)\n* More than 4 weeks since prior major surgery\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)\n* More than 4 weeks since prior radiotherapy\n* More than 1 month since prior investigational drugs, therapies, or devices\n* No prior radiotherapy to \\> 25% of bone marrow\n* No prior high-dose chemotherapy, either myeloablative or nonmyeloablative (mini-allogeneic transplant)\n* No more than 3 prior myelosuppressive chemotherapy regimens\n* Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month\n\n * Nasal, opthalmologic, and topical glucocorticoid preparations allowed\n * Physiologic hormone replacement therapies allowed (i.e., oral replacement glucocorticoid therapy for adrenal insufficiency)\n* No concurrent prophylactic hematopoietic growth factors\n* No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes\n\n * Radioisotopes for protocol specified positron emission tomography allowed\n* No other concurrent investigational agents\n* No other concurrent chemotherapy, radiotherapy (including palliative local radiotherapy), hormonal therapy (except for androgen-deprivation therapy), and/or biological therapy (including immunotherapy)'}, 'identificationModule': {'nctId': 'NCT00349167', 'briefTitle': 'PR-104 in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Proacta, Incorporated'}, 'officialTitle': 'A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': 'PR104-1001'}, 'secondaryIdInfos': [{'id': 'P30CA016042', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016042', 'type': 'NIH'}, {'id': 'UCLA-0512034-01A'}, {'id': 'PROACTA-PR-104-1001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PR-104', 'description': 'PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2', 'interventionNames': ['Drug: PR-104', 'Other: laboratory biomarker analysis', 'Other: pharmacological study']}], 'interventions': [{'name': 'PR-104', 'type': 'DRUG', 'armGroupLabels': ['PR-104']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['PR-104']}, {'name': 'pharmacological study', 'type': 'OTHER', 'armGroupLabels': ['PR-104']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Mark D. Pegram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proacta, Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}