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

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ClinicalTrials.gov Identifier: NCT00204633
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 16, 2009
Sponsor:
Information provided by:
University Hospital Tuebingen

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Dysgerminoma Drug: Darbepoetin alfa Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : July 2003
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. frequency of transfusions (reduction from 90% to 65%)

Secondary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00204633     History of Changes
Other Study ID Numbers: jth_004
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

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