Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 9:07 PM
Study NCT ID:
NCT00003712
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CCI-779 in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C401859', 'term': 'temsirolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-07-14', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'unspecified adult solid tumor, protocol specific', 'tumors metastatic to brain'], 'conditions': ['Brain and Central Nervous System Tumors', 'Metastatic Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, '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 I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety, tolerability, and maximum tolerated dose (MTD) of CCI-779 in patients with advanced solid tumors (part I) who are not receiving anticonvulsant therapy.\n* Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain metastases (part II) who are receiving anticonvulsant therapy.\n* Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients.\n\nOUTLINE: This is an open-label, dose-escalation study.\n\n* Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.\n\nThe maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.\n\n* Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.\n\nPROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study within 8 months, and 12 patients will be accrued for part II within 7 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\nPart I:\n\n* Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists\n* No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I)\n* Measurable or evaluable disease\n\nPart II:\n\n* Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists\n* Receiving anticonvulsants\n* Measurable or evaluable disease\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 3 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9 g/dL\n\nHepatic:\n\n* Bilirubin less than 1.5 mg/dL\n* AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases)\n\nRenal:\n\n* Creatinine less than 2 mg/dL\n\nCardiovascular:\n\n* No unstable angina\n* No myocardial infarction within past 6 months\n* No maintenance therapy for life-threatening arrhythmias\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* HIV negative\n* No active infection or other serious concurrent illness\n* Triglycerides no greater than 300 mg/dL\n* Cholesterol no greater than 350 mg/dL\n* No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin)\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed\n* No concurrent hormonal therapy\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 1 month since prior investigational agents\n* At least 3 weeks since prior immunosuppressive therapy\n* No concurrent anticonvulsant therapy (part I)\n* No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide)\n* No known agents that inhibit or induce cytochrome p450'}, 'identificationModule': {'nctId': 'NCT00003712', 'briefTitle': 'CCI-779 in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000066820'}, 'secondaryIdInfos': [{'id': 'P30CA054174', 'link': 'https://reporter.nih.gov/quickSearch/P30CA054174', 'type': 'NIH'}, {'id': 'UTHSC-9785011303', 'type': 'OTHER', 'domain': 'UTHSCSA IRB'}, {'id': 'SACI-IDD-98-02', 'type': 'OTHER', 'domain': 'San Antonio Cancer Institute'}, {'id': 'W-AR-3066K1-100-US', 'type': 'OTHER', 'domain': 'Wyeth'}, {'id': 'NCI-V98-1506', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'temsirolimus', 'type': 'DRUG', 'description': '•Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.\n\nThe maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.\n\n•Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '78229-3264', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Cancer Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Eric K. Rowinsky, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'San Antonio Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}