Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 1:08 PM
Study NCT ID:
NCT00045266
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2002-09-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent adult diffuse large cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult Burkitt lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'stage IV adult diffuse small cleaved cell lymphoma', 'stage IV adult Burkitt lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'stage IV adult lymphoblastic lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV mantle cell lymphoma', 'unspecified adult solid tumor, protocol specific', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'stage IV small lymphocytic lymphoma', 'stage IV marginal zone lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'splenic marginal zone lymphoma'], 'conditions': ['Lymphoma', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Dupont J, Camastra D, Gordon MS, et al.: Phase 1 study of VEGF Trap in patients with solid tumors and lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-776, 2003.'}, {'pmid': '20028764', 'type': 'RESULT', 'citation': 'Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors. Clin Cancer Res. 2010 Jan 1;16(1):358-66. doi: 10.1158/1078-0432.CCR-09-2103. Epub 2009 Dec 22.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.\n\nPURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131.\n* Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.\n* Determine the steady state concentration of VEGF Trap over time in these patients.\n* Determine whether patients develop antibodies to this therapy during extended exposure.\n\nOUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131.\n\nPatients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131.\n\nPatients are followed at approximately 30 days.\n\nPROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed incurable relapsed or refractory solid tumor or non-Hodgkin\'s lymphoma that has been treated on MSKCC-01131\n* Must have completed participation in protocol MSKCC-01131 through visit 16 and have shown evidence of stable disease or complete or partial remission of tumor burden and no evidence of symptomatic deterioration\n\n * No adverse event or toxicity which resulted in discontinuation of participation in protocol MSKCC-01131\n * If a patient experienced dose-limiting toxicity, then the patient must have demonstrated the ability to tolerate the same dose or a lower dose prior to entry in this study\n* No known or suspected squamous cell carcinoma of the lung\n* No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal) metastases during protocol MSKCC-01131\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 25 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 3,500/mm3\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n* Hemoglobin at least 9.0 g/dL\n* No severe or uncontrolled hematologic condition\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST and ALT no greater than 2 times ULN\n* Alkaline phosphatase no greater than 2 times ULN\n* PT, PTT, and INR normal\n\nRenal\n\n* Creatinine no greater than ULN\n* No 1+ or greater proteinuria\n* No severe or uncontrolled renal condition\n\nCardiovascular\n\n* No severe or uncontrolled cardiovascular condition\n\nPulmonary\n\n* No severe or uncontrolled pulmonary condition\n\nOther\n\n* No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap)\n* No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition\n* No severe or uncontrolled psychiatric condition or adverse social circumstance that would preclude study\n* No other condition that would preclude study\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective double-barrier contraception during and for at least 3 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)\n* No other concurrent immunotherapy\n\nChemotherapy\n\n* No concurrent standard chemotherapy\n\nEndocrine therapy\n\n* No concurrent adrenal corticosteroids except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency\n* No concurrent systemic hormonal contraceptive agents\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 30 days since prior investigational therapy other than VEGF Trap\n* No concurrent standard or other investigational anticancer agents\n* No concurrent herbal supplements ("nutraceuticals")\n* No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, aspirin, or other nonsteroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2 (COX-2) inhibitors for analgesia\n* No concurrent COX-2 inhibitors for tumor treatment or prophylaxis'}, 'identificationModule': {'nctId': 'NCT00045266', 'briefTitle': "VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma', 'orgStudyIdInfo': {'id': 'REGENERON-VGF-ST-0105'}, 'secondaryIdInfos': [{'id': 'MSKCC-02020'}, {'id': 'CDR0000256462', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-G-02-2101'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ziv-aflibercept', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jakob Dupont, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}