Darbepoetin Alfa in Patients With "Poor Prognosis" Germ C... | NCT00204633

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

NCT00204633

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Feb 16, 2009Estimated

Enrollment

108Actual

Phase

Phase 2

Conditions

Dysgerminoma

Interventions

Darbepoetin alfa

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2009

Last Update Posted Date

Feb 16, 2009Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Name	Type	Description	Arm Group Labels	Other Names
Darbepoetin alfa	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frequency of transfusions (reduction from 90% to 65%)

Secondary Outcomes

Measure	Description	Time Frame
proportion of patients with no transfusions
developing of hemoglobin levels
objective remission rate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joerg T. Hartmann, MD	South West German Cancer Center, Medical Center II, University of Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center II, University of Tuebingen		Tübingen		72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D004407	Dysgerminoma

Ancestor Terms

ID	Term
D018237	Germinoma
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068256	Darbepoetin alfa

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided