Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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