Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00054405
Status:
TERMINATED
Last Update Posted:
2013-04-09
First Post:
2003-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053765', 'term': 'Interleukin-12 Subunit p35'}, {'id': 'D018664', 'term': 'Interleukin-12'}, {'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D008222', 'term': 'Lymphokines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Administratively complete.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-08', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)', 'timeFrame': 'Up to 3 weeks'}]}, 'conditionsModule': {'conditions': ['Recurrent Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in treating young patients who have refractory or recurrent neuroblastoma. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining interleukin-2 with interleukin-12 may kill more tumor cells.', 'detailedDescription': 'OBJECTIVES:\n\nI. Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma.\n\nII. Determine, preliminarily, the antitumor effect of interleukin-12 with or without interleukin-2 in these patients.\n\nIII. Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients.\n\nIV. Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients.\n\nOUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 treatment cohorts.\n\nCOHORT A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12.\n\nCOHORT B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A.\n\nTreatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator.\n\nCohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 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\nOnce the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD.\n\nPatients are followed at 3 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of neuroblastoma\n\n * Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites\n* Persistent and/or refractory disease, with at least 1 of the following:\n\n * Biopsy-proven residual disease at least 12 weeks after myeloablative therapy\n * Progressive disease after nonmyeloablative or myeloablative therapy\n* Recurrent disease, evidenced by any of the following:\n\n * Biopsy-proven recurrent soft tissue disease\n * Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart\n * Histologically confirmed bone marrow disease\n * Progressive or stable disease after at least 1 prior standard salvage regime\n* No clinically significant pleural effusion\n* ECOG 0-1\n* Life expectancy \\>= 12 weeks\n* Hepatitis A antibody negative\n* Hepatitis B surface antigen negative\n\n * Positive hepatitis B titer allowed if patient has been immunized and has no history of disease\n* Hepatitis C virus negative\n* No history of congenital or acquired coagulation disorder\n* Cardiac function normal by ECG\n* No dyspnea at rest\n* No exercise intolerance\n* Oxygen saturation at least 94% by pulse oximetry\n* DLCO greater than 60% of predicted\n* FEV1 greater than 70% of predicted\n* Negative pregnancy test\n* Skull-based bony lesions without space-occupying intracranial extension are allowed\n* No prior or concurrent intracranial metastatic disease to the brain parenchyma\n* Not pregnant or nursing\n* Fertile patients must use effective barrier contraception during and for at least 2 months after study\n* No prior hematologic malignancy (including leukemia or lymphoma)\n* No history of malignant hyperthermia\n* No prior or concurrent autoimmune disease\n* No positive direct Coombs testing\n* No history of ongoing or intermittent bowel obstruction\n* No active infection or other significant systemic illness\n* More than 2 weeks since prior fenretinide\n* More than 2 weeks since prior 13-cis-retinoic acid\n* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)\n* More than 2 weeks since prior interferons or interleukins\n* More than 2 weeks since prior cytokine-fusion proteins\n* More than 2 weeks since prior IV immunoglobulin (IVIG)\n* No prior interleukin-12\n* No concurrent cytokines\n* No concurrent fenretinide\n* No concurrent 13-cis-retinoic acid\n* No other concurrent immunomodulators, including:\n\n * G-CSF and GM-CSF\n * Interferons\n * Other interleukins\n * IVIG\n* More than 4 weeks since prior chemotherapy\n* No other unstable medical condition or critical illness that would preclude study participation\n* More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem cell transplantation:\n\nNo prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation\n\n* More than 2 weeks since prior growth hormones\n* More than 4 weeks since prior systemic corticosteroids\n* More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral birth control pills)\n* No concurrent hormonal therapy (including oral birth control pills)\n* No concurrent growth hormones\n* No concurrent systemic corticosteroids, except for use in life-threatening complications\n* More than 4 weeks since prior radiotherapy\n* No prior solid organ transplantation\n* More than 4 weeks since prior investigational agents\n* No other concurrent investigational agents\n* No prior enrollment on COG-A3973, unless disease has progressed\n* No history of hemolytic anemia\n* Absolute neutrophil count at least 1,500/mm\\^3 \\[Note: Independent of growth factor or transfusion support\\]\n* Platelet count at least 75,000/mm\\^3 \\[Note: Independent of growth factor or transfusion support\\]\n* AST and ALT less than 2.5 times upper limit of normal\n* Bilirubin less than 2.0 mg/dL\n* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR creatinine normal\n* HIV negative\n* Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at least 30% by echocardiogram\n* No congestive heart failure\n* No uncontrolled cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT00054405', 'briefTitle': 'Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma', 'nctIdAliases': ['NCT00065494'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)', 'orgStudyIdInfo': {'id': 'NCI-2009-00024'}, 'secondaryIdInfos': [{'id': 'NANT 2001-01'}, {'id': 'CDR0000270447'}, {'id': 'P01CA081403', 'link': 'https://reporter.nih.gov/quickSearch/P01CA081403', 'type': 'NIH'}, {'id': 'CDR0000270447', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (IL-12, aldesleukin)', 'description': 'Cohort A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12.\n\nCohort B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A.\n\nTreatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator.\n\nCohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 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\nOnce the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD.', 'interventionNames': ['Biological: recombinant interleukin-12', 'Biological: aldesleukin']}], 'interventions': [{'name': 'recombinant interleukin-12', 'type': 'BIOLOGICAL', 'otherNames': ['cytotoxic lymphocyte maturation factor', 'IL-12', 'interleukin-12', 'natural killer cell stimulatory factor', 'Ro 24-7472'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (IL-12, aldesleukin)']}, {'name': 'aldesleukin', 'type': 'BIOLOGICAL', 'otherNames': ['IL-2', 'Proleukin', 'recombinant human interleukin-2', 'recombinant interleukin-2'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (IL-12, aldesleukin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027-6016', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'New Approaches to Neuroblastoma Treatment (NANT)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford University", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143-0875', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco - Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AFLAC Cancer Center and Blood Disorders Service', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Childrens Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan University Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Jon Wigginton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Approaches to Neuroblastoma Treatment (NANT)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}