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

Primary Purpose

Dysgerminoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Darbepoetin alfa
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysgerminoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center II, University of Tuebingen

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
February 13, 2009
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00204633
Brief Title
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysgerminoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Primary Outcome Measure Information:
Title
frequency of transfusions (reduction from 90% to 65%)
Secondary Outcome Measure Information:
Title
proportion of patients with no transfusions
Title
developing of hemoglobin levels
Title
objective remission rate
Title
progression-free- and overall-survival (pfs, os)
Title
quality of life

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg T. Hartmann, MD
Organizational Affiliation
South West German Cancer Center, Medical Center II, University of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center II, University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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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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