Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT00049361
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2002-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D013792', 'term': 'Thalidomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2004-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2002-11-12', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall median survival'}], 'secondaryOutcomes': [{'measure': 'Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter'}, {'measure': 'Median time to tumor progression'}, {'measure': 'Median time to neurologic response and progression'}, {'measure': 'Cause of death at median time'}, {'measure': 'Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter'}, {'measure': 'Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days'}]}, 'conditionsModule': {'keywords': ['adult tumors metastatic to brain', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Brain and Central Nervous System Tumors', '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. Radiation therapy uses high-energy x-rays to damage tumor cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide.\n* Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen.\n* Determine the cause of death of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n* Assess quality of life of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.\n\nPatients are followed at 1 and 3 months and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed extracranial primary malignancy or brain metastases\n* At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI\n* No evidence of spinal drop metastases or spread to noncontiguous meninges\n* No lymphoma, small cell lung cancer, or germ cell tumor\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* At least 4 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 10 g/dL\n\nHepatic\n\n* Bilirubin less than 1.5 mg/dL\n* SGPT and/or SGOT no greater than 2 times upper limit of normal\n\nRenal\n\n* Creatinine no greater than 1.5 mg/dL\n* BUN no greater than 25 mg/dL\n\nOther\n\n* Able to be regularly followed\n* No sensory neuropathy greater than grade 2\n* No other major medical illnesses that would preclude study\n* No neurologic or psychiatric impairments that would preclude study\n* No active infection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n* No other concurrent chemotherapy during and for 4 weeks after study\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy to head or neck\n* No prior stereotactic radiosurgery\n* Concurrent radiotherapy to extracranial sites of underlying malignancy allowed\n\nSurgery\n\n* Prior craniotomy allowed if completed within the past 10-28 days'}, 'identificationModule': {'nctId': 'NCT00049361', 'briefTitle': 'Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases', 'orgStudyIdInfo': {'id': 'REBACDR0000258057'}, 'secondaryIdInfos': [{'id': 'CCCWFU-91102'}, {'id': 'NCI-5883'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'temozolomide', 'type': 'DRUG'}, {'name': 'thalidomide', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Central Illinois', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '27534-9479', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '27157-1030', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Greenville', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Volker W. Stieber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}