Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT00006212
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2000-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'C000615311', 'term': 'Phosphorus-32'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-02', 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2004-05-25', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, '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. Drugs such as phosphorus-32 may make the tumor cells more sensitive to radiation therapy. Chemotherapy combined with radiation therapy and phosphorus-32 may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of phosphorus-32 plus radiation therapy and chemotherapy in treating patients who have stage II or stage III non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the dosimetry and toxicity of interstitial phosphorus P32 colloid plus chemotherapy and radiotherapy in patients with previously untreated stage II, IIIA, or IIIB non-small cell lung cancer. II. Determine the maximum tolerated dose of phosphorus P32 colloid in these patients. III. Determine the response in patients treated with this regimen.\n\nOUTLINE: This is a dose escalation study of phosphorus P32 colloid. Patients receive vinblastine IV on days 1, 8, 15, 22, and 29; cisplatin IV over 30-60 minutes on days 1 and 29; and phosphorus P32 colloid interstitially on day 50. Patients with tumor size less than 8.0 cm receive radiotherapy following phosphorus P32 injection 5 days a week for 6.5 weeks. Patients with tumor size greater than 8.0 cm receive radiotherapy 5 days a week for 4.5 weeks prior to phosphorus P32 injection, and for an additional 2.5 weeks following injection. Cohorts of 3 patients receive escalating doses of phosphorus P32 colloid until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically or cytologically confirmed, previously untreated stage II, IIIA, or IIIB non-small cell lung cancer Unresectable or inoperable disease OR Refusal of surgery Tumor reachable by CT guided needle placement Bidimensionally measurable disease by chest x-ray or CT scan No clinical/radiographic evidence of metastatic disease\n\nPATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Adequate hepatic function Renal: BUN no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Other: Less than 5% weight loss Able to receive induction chemotherapy No second malignancy within the past 5 years except skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to thorax Surgery: See Disease Characteristics No prior resection at primary site'}, 'identificationModule': {'nctId': 'NCT00006212', 'briefTitle': 'Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I Study of Interstitial Colloidal 32P Integrated With External Radiation Therapy and Chemotherapy in the Treatment of Non-Resectable or Medically Inoperable Non-Small Cell Carcinoma of the Lung', 'orgStudyIdInfo': {'id': 'CDR0000067812'}, 'secondaryIdInfos': [{'id': 'CMM-99003'}, {'id': 'NCI-V00-1586'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'vinblastine sulfate', 'type': 'DRUG'}, {'name': 'phosphorus P32', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Molecular Medicine', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}], 'overallOfficials': [{'name': 'Wayne S. Court, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Molecular Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Molecular Medicine', 'class': 'OTHER'}}}}