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Completed

NCT Number: NCT00204633

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

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

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Key information

Conditions

Dysgerminoma Germinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Medical Center II, University of Tuebingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

Primary outcomes

  1. frequency of transfusions (reduction from 90% to 65%)

Secondary outcomes

  1. proportion of patients with no transfusions

  2. developing of hemoglobin levels

  3. objective remission rate

  4. progression-free- and overall-survival (pfs, os)

  5. quality of life

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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