Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-30 @ 11:14 PM
Study NCT ID:
NCT00453232
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2007-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013724', 'term': 'Teratoma'}, {'id': 'C563236', 'term': 'Testicular Germ Cell Tumor'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D018239', 'term': 'Seminoma'}, {'id': 'D018236', 'term': 'Carcinoma, Embryonal'}, {'id': 'D018240', 'term': 'Endodermal Sinus Tumor'}], 'ancestors': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018237', 'term': 'Germinoma'}, {'id': 'D008649', 'term': 'Mesonephroma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2007-03-27', 'studyFirstSubmitQcDate': '2007-03-27', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity'}, {'measure': 'Feasibility'}], 'secondaryOutcomes': [{'measure': 'Response rate'}, {'measure': 'Progression-free survival'}]}, 'conditionsModule': {'keywords': ['stage III malignant testicular germ cell tumor', 'testicular choriocarcinoma and seminoma', 'testicular embryonal carcinoma and seminoma', 'testicular choriocarcinoma and embryonal carcinoma', 'testicular choriocarcinoma and teratoma', 'testicular choriocarcinoma', 'testicular choriocarcinoma and yolk sac tumor', 'testicular embryonal carcinoma and teratoma with seminoma', 'testicular embryonal carcinoma and teratoma', 'testicular embryonal carcinoma and yolk sac tumor with seminoma', 'testicular embryonal carcinoma and yolk sac tumor', 'testicular embryonal carcinoma', 'testicular seminoma', 'testicular yolk sac tumor', 'testicular yolk sac tumor and teratoma with seminoma', 'testicular yolk sac tumor and teratoma', 'recurrent malignant testicular germ cell tumor', 'recurrent extragonadal non-seminomatous germ cell tumor', 'recurrent extragonadal seminoma', 'stage IV extragonadal non-seminomatous germ cell tumor', 'stage IV extragonadal seminoma', 'adult teratoma', 'testicular immature teratoma', 'testicular mature teratoma', 'recurrent extragonadal germ cell tumor'], 'conditions': ['Extragonadal Germ Cell Tumor', 'Teratoma', 'Testicular Germ Cell Tumor']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.\n* Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.\n\nSecondary\n\n* Determine the response rate in patients treated with this regimen.\n* Determine the progression-free survival of patients treated with this regimen.\n\nOUTLINE: This is a non-randomized, pilot study.\n\nPatients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for 2 years.\n\nPROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients must fulfill all of the following criteria for 1 of the following diagnoses:\n\n * Nonseminoma germ cell tumor (intermediate risk)\n\n * Testis or retroperitoneal primary\n * Abnormal markers (alpha fetoprotein \\[AFP\\] \\> 1,000 and \\< 10,000 ng/mL, human chorionic gonadotropin \\[HCG\\] \\> 5,000 and \\< 50,000 IU/L, lactate dehydrogenase \\[LDH\\] \\> 1.5 times and \\< 10 times upper limit of normal \\[ULN\\])\n * No liver, bone, brain, or other nonpulmonary visceral metastasis\n * Histologic confirmation is not required if AFP or HCG are grossly elevated\n * Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:\n\n * Mediastinal primary\n * Nonpulmonary visceral metastases\n * Poor markers (AFP \\> 10,000 ng/mL, HCG \\> 50,000 IU/L, LDH \\> 10 times ULN)\n * Histologic confirmation not required if AFP or HCG are grossly elevated\n * Seminoma (intermediate prognosis)\n\n * Histological confirmation is required\n * Any primary site\n * Nonpulmonary visceral metastases must be present\n * Normal AFP\n * Any HCG\n * Any LDH\n * Surveillance relapse\n\n * Must fulfill appropriate criteria above according to initial histology\n\nPATIENT CHARACTERISTICS:\n\n* Neutrophil count ≥ 1,000/mm³\n* Platelet count ≥ 100,000/mm³\n* Must have adequate renal function (creatinine clearance ≥ 60 mL/min)\n* No prior malignancy except basal cell carcinoma\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy'}, 'identificationModule': {'nctId': 'NCT00453232', 'briefTitle': 'Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor', 'orgStudyIdInfo': {'id': 'CRCA-CCTC-ACCELERATED-BEP'}, 'secondaryIdInfos': [{'id': 'CDR0000537042', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EUDRACT-2004-000847-79'}, {'id': 'EU-20713'}, {'id': 'ISRCTN18505589', 'type': 'REGISTRY', 'domain': 'ISRCTN (International Standard Randomised Controlled Trial Number Register)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL'}, {'name': 'pegfilgrastim', 'type': 'BIOLOGICAL'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'EC1A 7BE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Northern Centre for Cancer Treatment at Newcastle General Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'OX3 7LJ', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Centre at Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Michael Williams, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}}}}