Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT00204633
Collaborator
(none)
108
Enrollment
1
Location
65.1
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Darbepoetin alfa
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 1, 2003
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00204633
Other Study ID Numbers:
  • jth_004
First Posted:
Sep 20, 2005
Last Update Posted:
Feb 16, 2009
Last Verified:
Feb 1, 2009
Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Dysgerminoma
Darbepoetin alfa

Study Results

No Results Posted as of Feb 16, 2009