Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-04 @ 3:30 PM
Study NCT ID:
NCT00060268
Status:
COMPLETED
Last Update Posted:
2011-03-09
First Post:
2003-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083998', 'term': '2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-07', 'studyFirstSubmitDate': '2003-05-06', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent esophageal cancer', 'stage I esophageal cancer', 'stage II esophageal cancer', 'stage III esophageal cancer', 'stage IV esophageal cancer'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy.\n* Determine, preliminarily, tumor response in patients treated with this drug.\n* Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients.\n* Determine plasma clearance rates for this drug in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\n* Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2.\n\nCohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity.\n\n* Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months.\n\nPROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed esophageal cancer\n\n * Stages T1-T3, any N, any M\n* Tumor partially or completely obstructing the esophagus\n* Primary or recurrent tumor meeting 1 of the following criteria for treatment:\n\n * Patient is too debilitated for or refused conventional therapy\n * Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery\n * Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician\n* Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH\n\n * Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site\n* No tracheal or bronchial involvement by bronchoscopy\n* No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 2,000/mm\\^3\n* Platelet count at least 50,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than 3.0 mg/dL\n* Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)\n* SGOT no greater than 3 times ULN\n* PT no greater than 1.5 times ULN\n\nRenal\n\n* Creatinine no greater than 3.0 mg/dL\n\nOther\n\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No contraindications to endoscopy\n* No porphyria\n* No hypersensitivity to porphyrins\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)'}, 'identificationModule': {'nctId': 'NCT00060268', 'briefTitle': 'Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)', 'orgStudyIdInfo': {'id': 'CDR0000301589'}, 'secondaryIdInfos': [{'id': 'RPCI-DS-9701'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'HPPH', 'type': 'DRUG', 'description': 'iv'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Hector R. Nava, MD, FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hector Nava, MD', 'oldOrganization': 'Roswell Park Cancer Institute'}}}}