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

University Hospital Tuebingen

Status and phase

Completed

Phase 2

Conditions

Dysgerminoma

Treatments

Drug: Darbepoetin alfa

Study type

Interventional

Funder types

Other

Identifiers

NCT00204633

jth_004

Details and patient eligibility

About

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

Enrollment

108 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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