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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
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
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

No publications provided

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:
Dysgerminoma
Neoplasms, Germ Cell and Embryonal
Germinoma
Neoplasms by Histologic Type
Neoplasms
 Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013