Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-01 @ 6:59 PM
Study NCT ID:
NCT00010192
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2001-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'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': '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': 'D000069283', 'term': 'Rituximab'}, {'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'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'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-05', 'studyFirstSubmitDate': '2001-02-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0', 'timeFrame': '2 weeks', 'description': 'Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.'}]}, 'conditionsModule': {'conditions': ['B-cell Adult Acute Lymphoblastic Leukemia', 'Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue', 'Nodal Marginal Zone B-cell Lymphoma', 'Noncontiguous Stage II Adult Burkitt Lymphoma', 'Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma', 'Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma', 'Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma', 'Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma', 'Noncontiguous Stage II Adult Lymphoblastic Lymphoma', 'Noncontiguous Stage II Grade 1 Follicular Lymphoma', 'Noncontiguous Stage II Grade 2 Follicular Lymphoma', 'Noncontiguous Stage II Grade 3 Follicular Lymphoma', 'Noncontiguous Stage II Mantle Cell Lymphoma', 'Noncontiguous Stage II Marginal Zone Lymphoma', 'Noncontiguous Stage II Small Lymphocytic Lymphoma', 'Recurrent Adult Acute Lymphoblastic Leukemia', 'Recurrent Adult Burkitt Lymphoma', 'Recurrent Adult Diffuse Large Cell Lymphoma', 'Recurrent Adult Diffuse Mixed Cell Lymphoma', 'Recurrent Adult Diffuse Small Cleaved Cell 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', 'Recurrent Marginal Zone Lymphoma', 'Recurrent Small Lymphocytic Lymphoma', 'Splenic Marginal Zone Lymphoma', 'Stage III Adult Burkitt Lymphoma', 'Stage III Adult Diffuse Large Cell Lymphoma', 'Stage III Adult Diffuse Mixed Cell Lymphoma', 'Stage III Adult Diffuse Small Cleaved Cell Lymphoma', 'Stage III Adult Immunoblastic Large Cell Lymphoma', 'Stage III Adult Lymphoblastic Lymphoma', 'Stage III Grade 1 Follicular Lymphoma', 'Stage III Grade 2 Follicular Lymphoma', 'Stage III Grade 3 Follicular Lymphoma', 'Stage III Mantle Cell Lymphoma', 'Stage III Marginal Zone Lymphoma', 'Stage III Small Lymphocytic Lymphoma', 'Stage IV Adult Burkitt 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 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', 'Stage IV Marginal Zone Lymphoma', 'Stage IV Small Lymphocytic Lymphoma']}, 'descriptionModule': {'briefSummary': "Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.", 'detailedDescription': 'OBJECTIVES: Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid malignancy.\n\nDetermine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population.\n\nDetermine the pharmacokinetics of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study of intermediate-dose pulse aldesleukin.\n\nPatients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed every 3 months for 1 year.\n\nPROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder\n\n * Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)\n * Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation\n* No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells\n* Measurable or evaluable disease\n* Must have failed standard curative therapy\n* No CNS or leptomeningeal metastasis\n* Performance status - Karnofsky 70-100%\n* Performance status - ECOG 0-1\n* At least 4 months\n* Absolute neutrophil count at least 1,000/mm\\^3\n* Hemoglobin at least 10 g/dL (transfusion allowed)\n* Platelet count at least 50,000/mm\\^3\n* AST no greater than upper limit of normal (ULN)\n* Bilirubin no greater than 1.5 times ULN\n* Hepatitis B surface antigen negative\n* Creatinine no greater than ULN\n* No prior unstable coronary artery disease\n* No New York Heart Association class III or IV congestive heart failure\n* DLCO and FEV1 at least 50% of predicted\n* HIV negative\n* No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No infection requiring IV antibiotic therapy within the past 4 weeks\n* No other major illness that would preclude study\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* See Disease Characteristics\n* Prior antibody therapy allowed\n* Prior interleukin-2 or interferon alfa allowed\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n* At least 4 weeks since prior systemic corticosteroids\n* At least 4 weeks since prior radiotherapy\n* At least 4 weeks since prior surgery'}, 'identificationModule': {'nctId': 'NCT00010192', 'briefTitle': 'Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial Of Rituximab And Interleukin-2', 'orgStudyIdInfo': {'id': 'NCI-2012-01404'}, 'secondaryIdInfos': [{'id': '0037'}, {'id': 'CDR0000068454'}, {'id': 'OSU-0037'}, {'id': 'NCI-130'}, {'id': 'OSU-00H0223'}, {'id': 'U01CA076576', 'link': 'https://reporter.nih.gov/quickSearch/U01CA076576', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (rituximab and aldesleukin)', 'description': 'Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84.', 'interventionNames': ['Biological: rituximab', 'Biological: aldesleukin', 'Other: laboratory biomarker analysis', 'Other: pharmacological study']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['IDEC-C2B8', 'IDEC-C2B8 monoclonal antibody', 'Mabthera', 'MOAB IDEC-C2B8', 'Rituxan'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (rituximab and aldesleukin)']}, {'name': 'aldesleukin', 'type': 'BIOLOGICAL', 'otherNames': ['IL-2', 'Proleukin', 'recombinant human interleukin-2', 'recombinant interleukin-2'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (rituximab and aldesleukin)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (rituximab and aldesleukin)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (rituximab and aldesleukin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Pierluigi Porcu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}