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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204633
First received: September 13, 2005
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose
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

Condition Intervention Phase
Dysgerminoma
 Drug: Darbepoetin alfa
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • frequency of transfusions (reduction from 90% to 65%)

Secondary Outcome Measures:
  • proportion of patients with no transfusions
  • developing of hemoglobin levels
  • objective remission rate
  • progression-free- and overall-survival (pfs, os)
  • quality of life
Enrollment: 108
Study Start Date: July 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204633

Locations
Germany
Medical Center II, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Joerg T. Hartmann, MD South West German Cancer Center, Medical Center II, University of Tuebingen
  More Information

ClinicalTrials.gov Identifier: NCT00204633     History of Changes
Other Study ID Numbers: jth_004 
Study First Received: September 13, 2005
Last Updated: February 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Dysgerminoma
Neoplasms by Histologic Type
Neoplasms
 Germinoma
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on September 27, 2016