Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-02-23 @ 12:12 AM
Study NCT ID:
NCT00110006
Status:
WITHDRAWN
Last Update Posted:
2010-06-11
First Post:
2005-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography Using Fludeoxyglucose F 18 in Predicting Response to Treatment in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}], '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': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], '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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2010-06-10', 'studyFirstSubmitDate': '2005-05-03', 'studyFirstSubmitQcDate': '2005-05-03', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment', 'timeFrame': 'at 7-10 days after R-CHOP, and after completion of study treatment'}, {'measure': 'Overall survival at 7-10 days after R-CHOP, and after completion of study treatment', 'timeFrame': 'at 7-10 days after R-CHOP, and after completion of study treatment'}, {'measure': 'Disease-free survival at 7-10 days after R-CHOP, and after completion of study treatment', 'timeFrame': 'at 7-10 days after R-CHOP, and after completion of study treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['contiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'stage I grade 3 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'stage I adult diffuse large cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'contiguous stage II mantle cell lymphoma', 'noncontiguous stage II mantle cell lymphoma', 'stage I mantle cell lymphoma', 'stage III mantle cell lymphoma', 'stage IV mantle cell lymphoma', 'anaplastic large cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells and allow doctors to plan better treatment. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.\n\nPURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F 18 to see how well it works in predicting response to treatment in patients who are receiving rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the positive and negative predictive values of early positron emission tomography (PET) scanning using fludeoxyglucose F 18 in terms of the probability of patients with newly diagnosed intermediate- or high-grade non-Hodgkin's lymphoma who achieve or do not achieve complete remission, after treatment with 1 course of rituximab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone.\n* Determine event free and overall survival of patients with an early positive and negative PET scan treated with this regimen.\n* Determine the predictive value of early PET scan response ratio as a continuous variable in terms of response to therapy (assessed at the end of therapy), disease-free survival, and overall survival, in patients treated with this regimen.\n* Correlate International Prognostic Index score at presentation with early PET scan results and overall outcome in patients treated with this regimen.\n* Correlate the degree of neutropenia 7 to 10 days after the first course of treatment with rituximab and combination chemotherapy with PET scan response and pre-treatment blood CD34-positive cell concentration in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive fludeoxyglucose F 18 (\\^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.\n\nPatients then receive standard R-CHOP (or an alternative regimen) comprising rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.\n\nPatients undergo repeat \\^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP. Patients also undergo radiographic restaging of their disease between courses 3 and 4 and at the completion of R-CHOP.\n\nAfter completion of study treatment, patients are followed every 3-4 months for 2 years, every 6 months for 1 year, and then annually for 3 years.\n\nPROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed newly diagnosed non-Hodgkin\'s lymphoma (NHL)\n\n * Intermediate- or high-grade disease\n * Stage I-IV disease\n * Any of the following subtypes are allowed:\n\n * Diffuse large B-cell lymphoma\n * Anaplastic large cell lymphoma\n * Mantle cell lymphoma\n * Grade 3 follicular lymphoma\n * Mediastinal B-cell lymphoma\n * The following subtypes are not allowed:\n\n * Lymphoblastic lymphoma\n * Mycosis fungoides/Sézary\'s syndrome\n * HTLV-1 associated T-cell leukemia or lymphoma\n * Primary CNS lymphoma\n * HIV-associated lymphoma\n * Transformed lymphoma\n * Burkitt\'s lymphoma\n* Adequate staging of lymphoma by any of the following methods:\n\n * CT scan or MRI of affected sites\n * Unilateral or bilateral bone marrow biopsy\n * Positive pre-treatment positron emission tomography (PET) scan\n * Lumbar puncture\n* Radiographically measurable disease by PET scan\n* Any International Prognostic Index risk category allowed\n* No prior diagnosis of another hematologic malignancy NOTE: A new classification scheme for adult non-Hodgkin\'s lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.\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* Absolute neutrophil count \\> 1,000/mm\\^3\\*\n* Platelet count ≥ 75,000/mm\\^3\\* NOTE: \\*Unless due to NHL\n\nHepatic\n\n* Bilirubin ≤ 2.0 mg/dL\\* (excluding Gilbert\'s disease) NOTE: \\*Unless due to NHL\n\nRenal\n\n* Creatinine ≤ 2.0 mg/dL (unless due to NHL)\n\nCardiovascular\n\n* Ejection fraction ≥ 45% by echocardiogram or MUGA\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No other malignancy within the past 5 years except superficial nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No other serious co-morbid disease that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior rituximab for NHL\n* No concurrent filgrastim \\[G-CSF\\] during course 1 of study treatment except for patients \\> 70 years of age OR patients with active infection\n\nChemotherapy\n\n* No prior chemotherapy for NHL\n\nEndocrine therapy\n\n* No prior steroids for NHL\n\nRadiotherapy\n\n* No prior radiotherapy for NHL\n* Concurrent consolidation radiotherapy to sites of bulky disease allowed at the discretion of the attending physician\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other prior treatment for NHL'}, 'identificationModule': {'nctId': 'NCT00110006', 'briefTitle': "Positron Emission Tomography Using Fludeoxyglucose F 18 in Predicting Response to Treatment in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': "Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CASE2404'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE-CWRU-2404', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'CWRU-100401'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'description': 'Rituximab IV over 3-6 hours. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.'}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'description': 'Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.'}, {'name': 'prednisone', 'type': 'DRUG', 'description': 'Oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.'}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'description': 'Vincristine IV over 5 minutes on day 1. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.'}, {'name': 'positron emission tomography', 'type': 'PROCEDURE', 'description': 'Beginning 1 hour after receiving fludeoxyglucose F 18, patients undergo whole-body positron emission tomography (PET) scanning. Patients undergo repeat \\^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP.'}, {'name': 'fludeoxyglucose F 18', 'type': 'RADIATION', 'description': 'Patients receive fludeoxyglucose F 18 (\\^18FDG) IV.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Panayiotis Savvides, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Panayiotis Savvides, MD', 'oldOrganization': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}}}}