Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT00003850
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-01', 'lastUpdateSubmitDate': '2013-02-07', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-06-02', 'lastUpdatePostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent metastatic squamous neck cancer with occult primary', 'metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the nasopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor.', 'detailedDescription': 'OBJECTIVES:\n\nI. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.\n\nII. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.\n\nOUTLINE:\n\nPatients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven squamous cell carcinoma of the head and neck\n* Recurrent disease OR metastatic disease at initial diagnosis or at recurrence\n* Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed\n* No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease\n* Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy\n\nPATIENT CHARACTERISTICS:\n\n* Age: 18 and over\n* Performance status: Zubrod 0-2\n* Life expectancy: At least 3 months\n* WBC at least 3000/mm3\n* Platelet count at least 100,000/mm3\n* Hematocrit at least 30%\n* Bilirubin no greater than 1.5 times normal\n* SGOT/SGPT no greater than 1.5 times normal\n* Creatinine no greater than 1.5 mg/dL\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study\n* Men must use effective barrier contraception during and for 1 month after study\n* No grade 2 or greater peripheral neuropathy\n* No serious infection or other concurrent illness requiring immediate therapy\n* Must be able to take oral medications\n* No medical or social factors that would interfere with compliance\n\nPRIOR CONCURRENT THERAPY:\n\n* Any number of courses of one regimen of chemotherapy allowed\n* No concurrent cytotoxic chemotherapy\n* No concurrent radiotherapy'}, 'identificationModule': {'nctId': 'NCT00003850', 'briefTitle': 'Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'NCI-2012-02299'}, 'secondaryIdInfos': [{'id': 'MDA-ID-98270'}, {'id': 'NCI-T98-0074'}, {'id': 'CDR0000067011', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.', 'interventionNames': ['Drug: thalidomide']}], 'interventions': [{'name': 'thalidomide', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Roy S. Herbst, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}