Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT00070304
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2003-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'New Zealand']}, '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': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-25', 'studyFirstSubmitDate': '2003-10-03', 'studyFirstSubmitQcDate': '2003-10-06', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Response Rate', 'timeFrame': 'Up to 1 year', 'description': 'Adequate tumor response is defined as achieving CR, VGPR or PR at any evaluation.'}], 'secondaryOutcomes': [{'measure': 'Toxicities', 'timeFrame': 'Up to 4 weeks following the completion of therapy', 'description': 'Toxic death, hepatic, cardiac or renal toxicity, hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities'}]}, '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']}, 'referencesModule': {'references': [{'pmid': '20863157', 'type': 'RESULT', 'citation': "Cole PD, McCarten KM, Drachtman RA, Alarcon Pd, Chen L, Trippett TM, Schwartz CL. Early [(1)(8)F]fluorodeoxyglucose positron emission tomography-based response evaluation after treatment with gemcitabine and vinorelbine for refractory Hodgkin disease: a children's oncology group report. Pediatr Hematol Oncol. 2010 Nov;27(8):650-7. doi: 10.3109/08880018.2010.504250."}, {'pmid': '19224841', 'type': 'RESULT', 'citation': "Cole PD, Schwartz CL, Drachtman RA, de Alarcon PA, Chen L, Trippett TM. Phase II study of weekly gemcitabine and vinorelbine for children with recurrent or refractory Hodgkin's disease: a children's oncology group report. J Clin Oncol. 2009 Mar 20;27(9):1456-61. doi: 10.1200/JCO.2008.20.3778. Epub 2009 Feb 17."}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use 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: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the response rate of pediatric patients with recurrent or refractory Hodgkin's lymphoma treated with gemcitabine and vinorelbine.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: This is a nonrandomized, multicenter study.\n\nPatients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 13-26 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 Hodgkin's lymphoma\\* with any of the following histologies:\n\n * Not otherwise specified (NOS)\n * Mixed cellularity NOS\n * Lymphocytic depletion\n\n * NOS\n * Diffuse fibrosis\n * Reticular\n * Lymphocytic predominance\n\n * NOS\n * Diffuse\n * Nodular\n * Paragranuloma\n * Granuloma\n * Sarcoma\n * Nodular sclerosis\n\n * Cellular phase\n * NOS\n * Lymphocytic predominance\n * Mixed cellularity\n * Lymphocytic depletion NOTE: \\*Disease metastatic to bone marrow with granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable for hematological toxicity\n* Measurable disease by clinical or radiographic criteria\n* Relapsed or refractory to conventional therapy\n\n * Received at least 2 prior cytotoxic chemotherapy regimens\n* No stage IA or IIA nodal disease previously treated with any of the following:\n\n * Radiotherapy only\n * No more than 4 courses of prior chemotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 30 and under\n\nPerformance status\n\n* Karnofsky 50-100% (over 16 years of age)\n* Lansky 50-100% (16 and under) OR\n* ECOG 0-2\n\nLife expectancy\n\n* At least 8 weeks\n\nHematopoietic\n\n* See Disease Characteristics\n* Absolute neutrophil count ≥ 750/mm\\^3\n* Platelet count ≥ 75,000/mm\\^3 (transfusion independent, defined as ≥ 3 days since prior platelet transfusion)\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* ALT ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR\n* Creatinine based on age as follows:\n\n * No greater than 0.8 mg/dL (age 5 and under)\n * No greater than 1.0 mg/dL (age 6 to 10)\n * No greater than 1.2 mg/dL (age 11 to 15)\n * No greater than 1.5 mg/dL (over age 15)\n\nPulmonary\n\n* DLCO ≥ 50%\n* FEV\\_1 ≥ 50%\n* Vital capacity ≥ 50%\n* No evidence of dyspnea at rest\n* No exercise intolerance\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study participation\n* Seizure disorder allowed provided patient is on anticonvulsants and disorder is well controlled\n* No evidence of active graft-versus-host disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Recovered from prior immunotherapy\n* At least 6 months since prior allogeneic stem cell transplantation (SCT)\n* At least 7 days since prior biologic agents\n* More than 3 months since prior autologous SCT\n* More than 1 week since prior growth factors\n* No concurrent immunomodulating agents\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered\n* No prior gemcitabine and vinorelbine in combination (i.e., administered within 1 week of each other)\n\n * Prior gemcitabine or vinorelbine administered alone is allowed\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent steroids, including corticosteroids as an antiemetic or for control of graft-versus-host disease\n\n * Concurrent corticosteroids allowed only for the following indications:\n\n * Adrenal crisis in patients with suppressed pituitary/adrenal response\n * Noncardiogenic pulmonary edema\n * Allergic reactions to amphotericin or transfusions treated with low-dose hydrocortisone (less than 100 mg/m\\^2)\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* Not specified\n\nOther\n\n* Concurrent immunosuppressive drugs allowed"}, 'identificationModule': {'nctId': 'NCT00070304', 'briefTitle': "Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma", 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': "A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease", 'orgStudyIdInfo': {'id': 'AHOD0321'}, 'secondaryIdInfos': [{'id': 'CDR0000331915', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'COG-AHOD0321', 'type': 'OTHER', 'domain': "Children's Oncology Group"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.', 'interventionNames': ['Biological: filgrastim', 'Drug: gemcitabine hydrochloride', 'Drug: vinorelbine tartrate']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Granulocyte Colony-Stimulating Factor', 'r-metHuG-CSF', 'G-CSF', 'Neupogen', 'NSC # 614629'], 'description': 'Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.', 'armGroupLabels': ['Treatment']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'otherNames': ['Gemzar', 'NSC #613327'], 'description': 'Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8', 'armGroupLabels': ['Treatment']}, {'name': 'vinorelbine tartrate', 'type': 'DRUG', 'otherNames': ['Navelbine', 'NSC #608210'], 'description': 'Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'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': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Institute at Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'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': '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': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Comprehensive Cancer Center - Stanford', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'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': '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': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'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': "Nemours Children's Clinic - 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