Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00275067
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide, Temozolomide, and Radiation Therapy in Treating Patients With Malignant Glioma That Has Been Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-18', 'releaseDate': '2023-12-21'}], 'estimatedResultsFirstSubmitDate': '2023-12-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'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': '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'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077237', 'term': 'Arsenic Trioxide'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D001152', 'term': 'Arsenicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2006-01-10', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of arsenic trioxide and temozolomide in combination with radiotherapy', 'timeFrame': 'Toxicity evaluated prior to each treatment cycle', 'description': 'Escalating doses of study drug until dose limiting toxicities are observed.'}, {'measure': 'Collect data on the toxicity of arsenic and temozolomide during radiation therapy', 'timeFrame': 'Toxicity evaluated prior to each treatment cycle', 'description': 'Toxicity of this drug combination during radiation therapy will be assessed.'}, {'measure': 'Assess serum biomarkers and correlate with tumor tissue', 'timeFrame': 'At baseline, during radiation therapy, and prior to each cycle of chemotherapy', 'description': 'Blood will be drawn at baseline, during radiation therapy, and prior to each cycle of chemotherapy to assess serum biomarkers and correlate with tumor tissue.'}], 'secondaryOutcomes': [{'measure': 'Determine progression free survival at 6 and 12 months', 'timeFrame': 'At 6 and 12 months after beginning chemotherapy', 'description': 'Patients will undergo an MRI and neurological evaluation every 6 months while on chemotherapy.'}, {'measure': 'Determine time to disease progression', 'timeFrame': 'At 6 and 12 months after beginning chemotherapy', 'description': 'Disease status will be assessed by MRI and neurological examination every 6 months until disease progression.'}, {'measure': 'To determine overall survival', 'timeFrame': 'Every 6 months while on treatment', 'description': 'Survival status will be evaluated every 6 months while on treatment.'}, {'measure': 'To determine radiographic response to study regimen', 'timeFrame': 'Every 6 months while on treatment', 'description': 'Radiographic response will be assessed by MRI every 6 months while on treatment'}, {'measure': 'To collect safety data during the radiation therapy phase', 'timeFrame': 'Weekly during radiation therapy', 'description': "EKG's will be done once per week and labs twice per week during radiation therapy phase to evaluate safety data."}, {'measure': 'To evaluate a potential surrogate marker for outcomes', 'timeFrame': 'At baseline, before and after radiation therapy, and every 2 cycles during chemotherapy', 'description': 'Blood will be drawn to analyze methylation patterns as a surrogate marker for outcomes at baseline, before and after radiation therapy, and every 2 cycles during chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult anaplastic astrocytoma', 'adult gliosarcoma', 'adult anaplastic oligodendroglioma', 'adult mixed glioma', 'adult glioblastoma', 'adult giant cell glioblastoma', 'recurrent adult brain tumor'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving arsenic trioxide and temozolomide together with radiation therapy after surgery may kill any remaining tumor cells.\n\nPURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide and temozolomide when given together with radiation therapy and to see how well they work in treating patients with malignant glioma that has been removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose (MTD) of arsenic trioxide and temozolomide when combined with radiotherapy in patients with resected supratentorial malignant glioma. (Phase I)\n* Determine the toxicity of this regimen in these patients. (Phase I)\n\nSecondary\n\n* Determine the 6- and 12-month progression-free survival of patients treated with this regimen once an MTD is reached. (Phase II)\n* Determine the radiographic response for patients treated with the above regimen. (Phase II)\n* Determine the safety of this regimen in these patients. (Phase II)\n\nOUTLINE: This is a phase I, dose-escalation study of arsenic trioxide and temozolomide followed by a phase II study.\n\n* Phase I: Patients undergo radiotherapy once daily 5 days a week and receive oral temozolomide once daily for approximately 6½ weeks. Patients also receive arsenic trioxide IV over 1-4 hours once daily, 5 days a week in week 1 and then twice a week in weeks 2-7. Beginning within 3-5 weeks after completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 1 year in the absence of disease progression and unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of arsenic trioxide and temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\n* Phase II: Patients undergo radiotherapy and receive arsenic trioxide and temozolomide as in phase I at the MTD. Patients then receive temozolomide as in phase I for up to 1 year in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for 1 year.\n\nPROJECTED ACCRUAL: A total of 12-18 patients will be accrued for the phase I portion of this study. A total of 25 patients will be accrued for the phase II portion of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed supratentorial malignant glioma of 1 of the following types:\n\n * Glioblastoma multiforme\n * Gliosarcoma\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n * Anaplastic mixed gliomas\n * Anaplastic gliomas not otherwise specified\n* Has undergone surgical resection of tumor\n\n * Patients with biopsy only are eligible\n * Evaluable or measurable disease following resection of recurrent tumor is not mandated for entry into the study\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* Life expectancy \\> 3 months\n* WBC \\> 3,000/mm\\^3\n* Absolute neutrophil count \\> 2,000/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n* Hemoglobin \\> 10 g/dL (eligibility level for hemoglobin may be reached by transfusion)\n* Creatinine ≤ 1.5 mg/dL\n* Bilirubin ≤ 2 mg/dL\n* Transaminases ≤ 2 times the upper limit of normal\n* Serum potassium\\* \\> 4.0 mEq/dL\n* Serum magnesium\\* \\> 1.8 mg/dL NOTE: \\*If these serum electrolytes are below the specified limits on the baseline laboratory tests, supplemental electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after completion of study treatment\n* No second-degree heart block\n* QT interval ≤ 460 msec\n* No other malignancy within the past 3 years except curatively treated carcinoma in situ or basal cell carcinoma of the skin\n* Patients who cannot undergo MRI are not eligible for this study\n* No other serious concurrent infection or other medical illness that would jeopardize the ability of the patient to receive the therapy in this protocol with reasonable safety\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Patients must have recovered from the effects of surgery prior to the start of treatment (10-14 days minimum) and be maintained on a stable corticosteroid regimen for 5 days\n* Concurrent glucocorticoid therapy allowed at the smallest effective dose\n* Patients must be on non-enzyme-inducing anti-convulsants to minimize any drug reaction\n* No prior radiation therapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy), or hormonal therapy for their brain tumor'}, 'identificationModule': {'nctId': 'NCT00275067', 'briefTitle': 'Arsenic Trioxide, Temozolomide, and Radiation Therapy in Treating Patients With Malignant Glioma That Has Been Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Phase I/II Trial of Arsenic Trioxide and Temozolomide in Combination With Radiation Therapy for Patients With Malignant Gliomas', 'orgStudyIdInfo': {'id': 'NU 04C1'}, 'secondaryIdInfos': [{'id': 'NU 04C1', 'type': 'OTHER', 'domain': 'Northwestern University'}, {'id': 'CDR0000456504', 'type': 'REGISTRY', 'domain': 'PDQ'}, {'id': 'STU00007792', 'type': 'OTHER', 'domain': 'Northwestern University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation + temozolomide and arsenic trioxide', 'description': 'Radiation therapy followed by the combination of temozolomide and arsenic trioxide at the maximum tolerated dose determined in phase 1', 'interventionNames': ['Drug: arsenic trioxide', 'Drug: temozolomide', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'arsenic trioxide', 'type': 'DRUG', 'otherNames': ['ATO', 'TRISENOX'], 'description': 'Arsenic trioxide administered intravenously at a dose of 0.20mg/kg Daily x 5 week then twice per week', 'armGroupLabels': ['Radiation + temozolomide and arsenic trioxide']}, {'name': 'temozolomide', 'type': 'DRUG', 'otherNames': ['TMZ', 'Temodar'], 'description': 'Temozolomide administered orally once per day 1 hour prior to radiation therapy at a dose of 75 mg/m2 x 42 days; at a dose of 200mg/m2 for 5 days every cycle (1 cycle = 28 days) after radiation therapy', 'armGroupLabels': ['Radiation + temozolomide and arsenic trioxide']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'All patients will receive 5940-6120 cGy of radiation therapy as 28-33 treatments/fractions (180-200 cGy/treatment) depending on whether they receive standard 3-D conformal radiation therapy or intensity modulated radiation therapy.', 'armGroupLabels': ['Radiation + temozolomide and arsenic trioxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-2998', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hematology-Oncology Associates of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Cancer Center', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}], 'overallOfficials': [{'name': 'Jeffrey Raizer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cephalon', 'class': 'INDUSTRY'}, {'name': 'CTI BioPharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-21', 'type': 'RELEASE'}, {'date': '2024-01-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Northwestern University'}}}}