Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00003067
Status:
SUSPENDED
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biological Therapy in Treating Patients With Primary or Advanced Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '1997-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult glioblastoma', 'adult anaplastic astrocytoma', 'adult mixed glioma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '8625188', 'type': 'RESULT', 'citation': 'Hayes RL, Koslow M, Hiesiger EM, Hymes KB, Hochster HS, Moore EJ, Pierz DM, Chen DK, Budzilovich GN, Ransohoff J. Improved long term survival after intracavitary interleukin-2 and lymphokine-activated killer cells for adults with recurrent malignant glioma. Cancer. 1995 Sep 1;76(5):840-52. doi: 10.1002/1097-0142(19950901)76:53.0.co;2-r.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma.\n\nPURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.", 'detailedDescription': 'OBJECTIVES:\n\n* Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas.\n* Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients.\n\nOUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction.\n\nPatients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter.\n\nDisease restaging is done every 8-12 weeks.\n\nPROJECTED ACCRUAL: A total of 30 patients per year will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma)\n\n * Must be a candidate for neurosurgical biopsy or tumor debulking\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance Status:\n\n* Karnofsky 60-100%\n\nLife Expectancy:\n\n* Greater than 4 months\n\nHematopoietic:\n\n* Granulocytes greater than 1,500/mm\\^3\n* Platelet count greater than 50,000/mm\\^3\n* PT and PTT within normal limits\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular:\n\n* No congestive heart failure\n* No coronary artery disease\n* No serious cardiac arrhythmias\n* No prior myocardial infarction\n\nPulmonary:\n\n* No major pulmonary problems\n\nOther:\n\n* No history of neurologic disease (except related to brain tumor)\n* No psychosis\n* No impaired cognitive function\n* No significant concurrent medical illness\n* No active infection requiring antibiotic therapy\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device\n* No hepatitis B or C\n* HIV negative\n* No prior autoimmune disease\n* Allergy to gentamicin is allowed\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 6 weeks since prior immunotherapy and recovered\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* Reduction or elimination of corticosteroids\n* Not greater than 0.15 mg/kg/day dexamethasone equivalent\n\nRadiotherapy:\n\n* At least 6 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy\n\nSurgery:\n\n* Prior surgery is allowed\n\nOther:\n\n* Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed'}, 'identificationModule': {'nctId': 'NCT00003067', 'briefTitle': 'Biological Therapy in Treating Patients With Primary or Advanced Glioma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas', 'orgStudyIdInfo': {'id': 'CDR0000065739'}, 'secondaryIdInfos': [{'id': 'NYWCCC-0902499'}, {'id': 'NYWCCC-IMMUNE-0902499'}, {'id': 'SIUH-RP-96-004'}, {'id': 'NCI-V97-1326'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'lymphokine-activated killer cells', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'Roberta L. Hayes, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Immune Therapy, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}}}}