Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
NCT ID: NCT00204633
Last Updated: 2009-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2003-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Darbepoetin alfa
Eligibility Criteria
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Inclusion Criteria
* Primary mediastinal tumor
* Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
* Poor marker: AFP \> 10.000 ng/ml or beta-HCG \> 10.000 ng/ml (50.000 IU/l) andd LDH \>10 x upper normal limit
* No previous chemotherapy
* Age \> 18 years
* Performance-Status: WHO =\< 2
* Written informed consent
* Ability to give informed consent
Exclusion Criteria
* Hematological disease with insufficient erythropoiesis
* Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
* Uncontrolled arterial hypertension
* Treatment with rh-Erythropoetin during trial
* Creatinin clearance \< 50 ml/min
* Insufficient bone marrow function (WBC count \< 3.000/ml or platelets \< 100.000/µl)
* Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease
* Second malignancy, except of completely resected basal cell carcinoma of the skin
18 Years
65 Years
MALE
No
Sponsors
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University Hospital Tuebingen
OTHER
Principal Investigators
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Joerg T. Hartmann, MD
Role: PRINCIPAL_INVESTIGATOR
South West German Cancer Center, Medical Center II, University of Tuebingen
Locations
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Medical Center II, University of Tuebingen
Tübingen, , Germany
Countries
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Other Identifiers
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jth_004
Identifier Type: -
Identifier Source: org_study_id
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