Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-26 @ 5:54 AM
Study NCT ID:
NCT00079092
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant 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': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'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': 'D011344', 'term': 'Procarbazine'}, {'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2006-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-08', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion'}, {'measure': 'Overall survival by follow-up form at study completion'}, {'measure': 'Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion'}, {'measure': 'Toxicity by evaluation form at baseline, pre-odd cycles, and study completion'}]}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult glioblastoma', 'adult mixed glioma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine.\n\nSecondary\n\n* Determine the progression-free survival of patients treated with this regimen.\n* Determine the overall survival of patients treated with this regimen.\n* Determine the quality of life of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline and then before every odd course.\n\nPatients are followed every 2 months.\n\nPROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant glioma\n\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n * Glioblastoma multiforme\n * Anaplastic mixed oligoastrocytoma\n* Progressive or recurrent disease\\* after radiotherapy with or without chemotherapy NOTE: \\*Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible\n* Measurable disease by MRI or CT scan\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* More than 2 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 mg/dL\n* Transaminases ≤ 4 times upper limit of normal\n\nRenal\n\n* Creatinine ≤ 1.7 mg/dL\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment\n* No concurrent serious infection\n* No other concurrent medical illness that would preclude study treatment\n* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior thalidomide\n* No concurrent prophylactic filgrastim (G-CSF)\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n* No prior procarbazine\n* No more than 2 prior chemotherapy regimens for malignant glioma\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 3 months since prior radiotherapy\n\nOther\n\n* Recovered from prior therapy\n* More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors)\n* No concurrent antidepressants\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00079092', 'briefTitle': 'Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas', 'orgStudyIdInfo': {'id': 'REBACDR0000354204'}, 'secondaryIdInfos': [{'id': 'CCCWFU-91202'}, {'id': 'NCI-6358'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'procarbazine hydrochloride', 'type': 'DRUG'}, {'name': 'thalidomide', 'type': 'DRUG'}]}, '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': '27157-1096', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Comprehensive Cancer Center', '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': 'Glenn J. Lesser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Edward G. Shaw, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Volker W. Stieber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', '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'}}}}