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

Dysgerminoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204633
• Other study ID #: jth_004
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 13, 2009
• Start date: July 2003
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysgerminoma

Intervention

Drug:
• Darbepoetin alfa

Locations

Country	Name	City	State
Germany	Medical Center II, University of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of transfusions (reduction from 90% to 65%)
Secondary	proportion of patients with no transfusions
Secondary	developing of hemoglobin levels
Secondary	objective remission rate
Secondary	progression-free- and overall-survival (pfs, os)
Secondary	quality of life