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:

Drug Information available for: Darbepoetin Alfa

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)
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

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

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 May 25, 2017

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