Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT00006760
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2000-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'New Zealand', 'Puerto Rico', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'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': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-25', 'studyFirstSubmitDate': '2000-12-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'After 2 cycles', 'description': 'Overall response includes complete response (CR) or partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg', 'timeFrame': 'After 2 cycles', 'description': 'Will be calculated.'}, {'measure': 'Biologic markers', 'timeFrame': 'At enrollment and during/after therapy'}, {'measure': 'Cardiac, hepatic, renal, hematologic toxicity', 'timeFrame': 'Within 1 month of completion of therapy'}, {'measure': 'Toxic death', 'timeFrame': 'Within 1 month of Completion of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent/refractory childhood Hodgkin lymphoma', 'childhood lymphocyte predominant Hodgkin lymphoma', 'childhood lymphocyte depletion Hodgkin lymphoma', 'childhood nodular sclerosis Hodgkin lymphoma', 'childhood mixed cellularity Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the response rate (overall and within strata) in both minimally pretreated, low-risk and heavily pretreated, high-risk children with refractory or relapsed Hodgkin's lymphoma treated with ifosfamide and vinorelbine with filgrastim (G-CSF).\n* Determine the cardiac, hepatic, renal, and hematologic toxicity of this regimen in minimally-pretreated, low-risk patients.\n* Determine the toxic death rate in minimally pretreated, low-risk patients treated with this regimen.\n* Determine whether this treatment regimen can mobilize sufficient hematopoietic stem cells (CD34) for subsequent stem cell transplantation in minimally pretreated, low-risk patients.\n* Determine the incidence of hypermutability by longitudinal genotoxic biomonitoring of patients treated with this regimen.\n* Determine the prognostic significance of biological markers, including serum interleukin (IL)-10 receptor, serum IL-2 receptor, p53, and mdm-2 in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients are stratified by prior therapy (minimally pretreated, low-risk vs heavily pretreated, high-risk).\n\nPatients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator.\n\nHeavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.\n\nPatients are followed at 1, 6, and 12 months and then periodically thereafter.\n\nPROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 1.5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed refractory or relapsed Hodgkin's lymphoma\n\n * Mixed cellularity, not otherwise specified (NOS)\n * Lymphocytic depletion, NOS\n * Lymphocytic depletion, diffuse fibrosis\n * Lymphocytic depletion, reticular\n * Lymphocytic predominance, NOS\n * Lymphocytic predominance, diffuse\n * Lymphocytic predominance, nodular\n * Hodgkin's paragranuloma NOS\n * Hodgkin's granuloma\n * Hodgkin's sarcoma\n * Nodular sclerosis, NOS\n * Nodular sclerosis, cellular phase\n * Nodular sclerosis, lymphocytic predominance\n * Nodular sclerosis, mixed cellularity\n * Nodular sclerosis, lymphocytic depletion\n * Other (type not specified)\n* In first relapse\n* Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed\n* Not enrolled on POG-9426 unless there is an extranodal site of recurrence\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Under 30 at diagnosis\n\nPerformance status:\n\n* Lansky 60-100% (for patients 16 years and under)\n* Karnofsky 60-100% (for patients over 16 years)\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* See Disease Characteristics\n* Absolute neutrophil count at least 1,000/mm\\^3\n* Platelet count at least 75,000/mm\\^3 (transfusion independent)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* SGOT or SGPT less than 2.5 times normal\n\nRenal:\n\n* Creatinine no greater than 1.5 times normal\n* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\n\nCardiovascular:\n\n* Shortening fraction at least 27% by echocardiogram OR\n* Ejection fraction at least 50% by gated radionuclide\n\nOther:\n\n* No other concurrent serious illness\n* No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunomodulating agents\n\nChemotherapy:\n\n* At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered\n* No other concurrent anticancer chemotherapy\n\nEndocrine therapy:\n\n* No concurrent steroids\n* No concurrent corticosteroids (e.g., dexamethasone)\n\nRadiotherapy:\n\n* Recovered from prior radiotherapy\n\nSurgery:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00006760', 'briefTitle': "Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma", 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': "A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease", 'orgStudyIdInfo': {'id': 'AHOD00P1'}, 'secondaryIdInfos': [{'id': 'CCG-A5981', 'type': 'OTHER', 'domain': "Children's Cancer Group"}, {'id': 'CDR0000068325', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'NCI-2012-02366', 'type': 'OTHER', 'domain': 'NCI'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (ifosfamide, vinorelbine, filgrastim)', 'description': 'Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.', 'interventionNames': ['Biological: filgrastim', 'Drug: ifosfamide', 'Drug: vinorelbine tartrate']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'description': 'subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.', 'armGroupLabels': ['Treatment (ifosfamide, vinorelbine, filgrastim)']}, {'name': 'ifosfamide', 'type': 'DRUG', 'description': 'V over 24 hours on days 1-4', 'armGroupLabels': ['Treatment (ifosfamide, vinorelbine, filgrastim)']}, {'name': 'vinorelbine tartrate', 'type': 'DRUG', 'description': 'IV over 6-10 minutes on days 1 and 5.', 'armGroupLabels': ['Treatment (ifosfamide, vinorelbine, filgrastim)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016-7710', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242-2814', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '90801', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Jonathan Jaques Children's Cancer Center at Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93638-8762', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Oakland', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123-4282', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital and Health Center - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center at Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218-1088', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Cancer Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06360-2875', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Comprehensive Cancer Center at Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010-2970', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Cancer Care of Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610-0232', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Miami Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803-1273', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute at Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Cancer Center at Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Cancer Institute at St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Kaplan Cancer Center at St. Mary's Medical Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '31403-3089', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '95813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Cancer Research Center of Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83712-6297', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Mountain States Tumor Institute - 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Butterworth Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48236', 'city': 'Grosse Pointe Woods', 'state': 'Michigan', 'country': 'United States', 'facility': 'Van Elslander Cancer Center at St. John Hospital and Medical Center', 'geoPoint': {'lat': 42.44365, 'lon': -82.90686}}, {'zip': '49007-5341', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Kalamazoo', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospital of Minnesota - Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '39534-2511', 'city': 'Keesler Air Force Base', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Keesler Medical Center - 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