Status:
COMPLETED
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Dysgerminoma
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa
Eligibility Criteria
Inclusion
- Poor prognosis" according IGCCCG-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
- Hemolysis
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00204633
Start Date
July 1 2003
End Date
December 1 2008
Last Update
February 16 2009
Active Locations (1)
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1
Medical Center II, University of Tuebingen
Tübingen, Germany, 72076