Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00066651
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2003-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D001948', 'term': 'Brenner Tumor'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D018225', 'term': 'Neoplasms, Fibroepithelial'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C474515', 'term': 'SS1(dsFv)PE38'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'statusVerifiedDate': '2006-02', 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2003-08-06', 'studyFirstSubmitQcDate': '2003-08-06', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['ovarian carcinosarcoma', 'ovarian clear cell cystadenocarcinoma', 'ovarian endometrioid adenocarcinoma', 'ovarian mixed epithelial carcinoma', 'ovarian serous cystadenocarcinoma', 'ovarian undifferentiated adenocarcinoma', 'recurrent ovarian epithelial cancer', 'Brenner tumor', 'primary peritoneal cavity cancer', 'fallopian tube cancer', 'epithelial mesothelioma', 'recurrent malignant mesothelioma', 'recurrent pancreatic cancer', 'cervical squamous cell carcinoma', 'recurrent cervical cancer', 'recurrent non-small cell lung cancer', 'squamous cell lung cancer', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent metastatic squamous neck cancer with occult primary', 'recurrent salivary gland cancer', 'salivary gland squamous cell carcinoma', 'recurrent squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the nasopharynx'], 'conditions': ['Cervical Cancer', 'Fallopian Tube Cancer', 'Head and Neck Cancer', 'Lung Cancer', 'Malignant Mesothelioma', 'Ovarian Cancer', 'Pancreatic Cancer', 'Primary Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies.\n\nSecondary\n\n* Determine the toxic effects of this drug in these patients.\n* Determine the plasma pharmacokinetics of this drug in these patients.\n* Determine the response in patients treated with this drug.\n* Correlate the induction of antibody against this drug with its pharmacokinetics in these patients.\n\nOUTLINE: This is an open-label, dose-escalation study.\n\nPatients receive a test dose of SS1(dsFv)-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 3-15 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 advanced malignancy of 1 of the following types:\n\n * Ovarian cancer\n\n * All nonmucinous epithelial histologies are eligible\n * Primary peritoneal cavity cancer\n * Fallopian tube cancer\n * Malignant mesothelioma\n\n * No sarcomatous histology\n * Pancreatic cancer\n * Squamous cell cancer (SCC) of the lung\n * SCC of the cervix\n * SCC of the head and neck\n* Recurrent unresectable disease, meeting 1 of the following criteria:\n\n * Previously treated with definitive standard therapy\n * Patient refused prior standard therapy\n* Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry\\* NOTE: \\*Immunohistochemical evaluation not required for patients with pancreatic cancer\n* Measurable or evaluable disease\n* No clinically significant pericardial effusion\n* No known CNS or spinal cord involvement by tumor\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 75,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* AST and ALT no greater than 2.5 times ULN\n* Albumin at least 3.0 g/dL\n* Hepatitis B and C negative\n\n * Seropositive allowed if clinically asymptomatic\n* except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria\n\nRenal\n\n* Creatinine no greater than ULN\n* Calcium no greater than ULN\n\nCardiovascular\n\n* No New York Heart Association class II-IV cardiovascular disease\n\nPulmonary\n\n* Oxygen saturation at least 93% on room air\n* DLCO at least 50% of predicted\\*\n* Total lung capacity and vital capacity at least 50% of predicted\\*\n* FEV\\_1 at least 50% of predicted\\* NOTE: \\*For patients with pleural mesothelioma and as clinically indicated\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No infection requiring parenteral antibiotics\n* No HIV infection\n* Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75%\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 4 weeks since prior therapy and recovered\n* No other concurrent antitumor therapy'}, 'identificationModule': {'nctId': 'NCT00066651', 'briefTitle': 'Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors', 'nctIdAliases': ['NCT00065481'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing', 'orgStudyIdInfo': {'id': 'CDR0000316451'}, 'secondaryIdInfos': [{'id': 'NCI-03-C-0243'}, {'id': 'NCI-6221'}, {'id': 'NCI-SS1PE-002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SS1(dsFv)-PE38 immunotoxin', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '27157-1096', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Raffit Hassan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}