Clinical trial · Interventional
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)
NCT00204633CI-TRIAL-00002056completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysgerminoma | Dysgerminoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- frequency of transfusions (reduction from 90% to 65%)
Secondary outcomes (5)
- measure
- proportion of patients with no transfusions
- measure
- developing of hemoglobin levels
- measure
- objective remission rate
- measure
- progression-free- and overall-survival (pfs, os)
- measure
- quality of life
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.