Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-26 @ 6:11 AM
Study NCT ID:
NCT00387504
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2006-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017313', 'term': 'Fenretinide'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-10', 'studyFirstSubmitDate': '2006-10-12', 'studyFirstSubmitQcDate': '2006-10-12', 'lastUpdatePostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of fenretinide', 'timeFrame': 'at end of study'}, {'measure': 'Toxicity as measured by type (organ affected or laboratory determination such as absolute neutrophil count), severity (NCI CTCAE v3.0), time of onset (course number), duration, and reversibility or outcome', 'timeFrame': 'ongoing'}, {'measure': 'Survival and time to failure as measured by Kaplan-Meier', 'timeFrame': 'at end of study'}]}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fenretinide, 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 fenretinide in treating patients with metastatic or unresectable malignant solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of fenretinide in patients with metastatic or unresectable malignant solid tumors.\n* Determine the toxic effects of this drug in these patients.\n* Determine the pharmacokinetics and in vivo activity of this drug in these patients.\n* Determine, preliminarily, disease or tumor response in patients treated with this drug.\n\nOUTLINE: This is a dose-escalation, multicenter study.\n\nPatients receive fenretinide IV continuously on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair.\n\nCohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.\n\nPatients undergo blood sample collection to determine plasma concentrations (pharmacokinetics) of fenretinide periodically during course 1 and at the end of courses 2-6.\n\nAfter completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 21 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 malignancy\n\n * Metastatic and/or unresectable disease\n* No standard curative or palliative measures exist or remain effective\n* Measurable or evaluable disease\n* No known brain metastases unless previously resected or irradiated with no treatment with steroids for more than 1 month\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%\n* Life expectancy \\> 3 months\n* WBC ≥ 3,000/mm³\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 75,000/mm³\n* Bilirubin \\< 1.5 times upper limit of normal (ULN)\n* AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with known liver metastases)\n* Creatinine normal OR creatinine clearance ≥ 60 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception prior to, during, and for ≥ 6 months after completion of study treatment\n* No uncontrolled diabetes mellitus at high risk for hypertriglyceridemia (i.e., fasting serum glucose concentration \\> 200 mg/dL OR hemoglobin A1C \\> 7.5%)\n* No egg allergy\n* No history of allergic reactions to compounds of similar chemical or biologic composition to fenretinide (e.g., isotretinoin, vitamin A, or tretinoin)\n* No uncontrolled intercurrent illness including, but not limited to, any of the following:\n\n * Ongoing or active infection\n * Symptomatic congestive heart failure\n * Unstable angina pectoris\n * Cardiac arrhythmia\n * Psychiatric illness or social situation that would preclude compliance with study requirements\n* No known hypertriglyceridemia requiring medication\n* No identified familial hyperlipidemia disorder\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from all prior therapy\n* Prior treatment with oral fenretinide is allowed provided no severe toxicity occurred\n* At least 2 weeks since prior major surgery\n* More than 4 weeks since prior chemotherapy or radiotherapy\n\n * At least 6 weeks since prior nitrosoureas or mitomycin C\n* No other concurrent investigational agents\n* No other concurrent anticancer chemotherapy\n* No other concurrent antioxidants\\*\n* No concurrent hormone-ablative agents, including steroids, except for adrenal replacement or anti-inflammatory indications\n* No other concurrent anticancer agents or therapies\n* No concurrent herbal or other alternative therapies\\*\n* No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)\\*\n\n * Standard-dose multivitamin allowed\n* No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, p-glycoprotein, multidrug resistance protein 1 (MRP1), or MRP1 drug/lipid transporters, including any of the following\\*:\n\n * Cyclosporine or any of its analogues\n * Verapamil\n * Tamoxifen or its analogue\n * Ketoconazole\n * Chlorpromazine\n * Mifepristone\n * Indomethacin\n * Sulfinpyrazone NOTE: \\*Patients who have discontinued these drugs for ≥ 1 week are eligible\n* No concurrent medications that may cause pseudotumor cerebri, including any of the following:\n\n * Tetracycline\n * Nalidixic acid\n * Nitrofurantoin\n * Phenytoin\n * Sulfonamides\n * Lithium\n * Amiodarone\n* No concurrent total parenteral nutrition (TPN) with intralipids\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00387504', 'briefTitle': 'Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors', 'organization': {'class': 'NETWORK', 'fullName': 'California Cancer Consortium'}, 'officialTitle': 'Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000508770'}, 'secondaryIdInfos': [{'id': 'U01CA062505', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062505', 'type': 'NIH'}, {'id': 'CCC-PHI-54'}, {'id': 'NCI-7540'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fenretinide', 'type': 'DRUG', 'description': '4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days. Cycle is repeated every 3 weeks, if PR, CR or stable disease for 6 cycles.'}, {'name': 'pharmacological study', 'type': 'OTHER', 'description': 'samples drawn per protocol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90027-0700', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94553', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Contra Costa Regional Medical Center', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Group', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Jacek Pinski, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Cancer Consortium', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}