Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-28 @ 7:41 AM
Study NCT ID:
NCT00515892
Status:
UNKNOWN
Last Update Posted:
2007-08-14
First Post:
2007-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541974', 'term': 'immunotoxin HA22'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-10', 'studyFirstSubmitDate': '2007-08-10', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.'}], 'secondaryOutcomes': [{'measure': 'To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leukemia', "Non-Hodgkin's Lymphoma", 'NHL']}, 'referencesModule': {'references': [{'pmid': '16061911', 'type': 'BACKGROUND', 'citation': 'Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy.\n\nPURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\nDISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of B-cell non-Hodgkin's lymphoma\n* Measurable disease\n* Evidence of CD22-positive malignancy by the following criteria,\n\n * \\> 30% of malignant cells from a disease site CD22+ by FACS analysis or,\n * \\> 15% of malignant cells from a disease site must react with anti-CD22 by immunohistochemistry\n* Patients with indolent subtypes of CD22+ B-cell non-Hodgkin's lymphoma, including, but not limited to mantle cell lymphoma, follicular lymphoma and Waldenström's macroglobulinemia, are eligible if stage III-IV.\n* Patients must have failed at least two or more courses of prior standard chemotherapy and/or biologic therapy (e.g. Rituxan). Patients with progressive mantle cell lymphoma may be eligible if they have failed one prior standard therapeutic regimen.\n\nPATIENTS CHARACTERISTICS\n\nPerformance Status\n\n* ECOG 0-2\n\nLife Expectancy\n\n* Life expectancy of less than 6 months, as assessed by the principal investigator\n\nOther\n\n* Patients with other cancers who meet eligibility criteria and have less than 5 years of disease free survival will be considered on a case-by-case basis\n* Must be able to understand and sign informed consent\n* Female and male patients must agree to use an approved method of contraception during the study\n\nExclusion Criteria:\n\n* History of bone marrow transplant\n* Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)\n* Pregnant or breast-feeding females\n* Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.\n* HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)\n* Hepatitis B surface antigen positive\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements\n\nHepatic function: serum transaminases (either ALT or AST) or bilirubin\n\n* ≥ Grade 2, unless bilirubin is due to Gilbert's disease\n\nRenal function: Serum creatinine clearance ≤ 60mL/min as estimated by Cockroft-Gault formula\n\nHematologic function:\n\n* The ANC \\< 1000/cmm, or platelet count \\<50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy).\n* A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies\n* Baseline coagulopathy \\> Grade 3 unless due to anticoagulant therapy.\n\nPulmonary function:\n\n* Patients with \\< 50% of predicted forced expiratory volume (FEV1) or \\<50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patient with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed after bronchodilator therapy.\n\nRecent prior therapy:\n\n* Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole body electron beam radiation therapy, hormonal, biologic or other standard or any investigational therapy of the malignancy for 3 weeks prior to entry into the trial\n* Less than or equal \\< 3 months prior monoclonal antibody therapy (i.e. rituximab)\n* Patients who are receiving or have received radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port\n* Any history of prior pseudomonas-exotoxin immunotoxin (PE) administration."}, 'identificationModule': {'nctId': 'NCT00515892', 'acronym': 'NHL', 'briefTitle': 'Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease', 'nctIdAliases': ['NCT00522483'], 'organization': {'class': 'OTHER', 'fullName': 'Cambridge Antibody Technology'}, 'officialTitle': "A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)", 'orgStudyIdInfo': {'id': 'CAT-8015-1003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immunotoxin therapy', 'type': 'DRUG'}, {'name': 'CAT-8015 Immunotoxin', 'type': 'DRUG'}, {'name': 'Biological therapy', 'type': 'PROCEDURE'}, {'name': 'Antibody Therapy', 'type': 'PROCEDURE'}, {'name': 'Monoclonal Antibody Therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marie Fuerst, RN, MS', 'role': 'CONTACT', 'phone': '310-285-7269'}, {'name': 'Peter Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tower Hematology Oncology Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'NCI Clinical Trials Referral Office', 'role': 'CONTACT', 'phone': '888-624-1937'}, {'name': 'Robert J Kreitman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Lodz', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Jamroziak, MD', 'role': 'CONTACT', 'phone': '(48) 42 689-5191'}, {'name': 'Tadeusz Robak, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge Antibody Technology', 'class': 'OTHER'}}}}