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Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)

Primary Purpose

Glioblastoma Multiforme

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cetuximab
Temozolomide
Radiation therapy
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Cetuximab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >= 18 and < 70 years of age Karnofsky Performance Score >= 60 histologically confirmed supratentorial GBM interval between primary diagnosis and registration for the study < 4 weeks patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3 adequate blood values (not older than 14 days prior to initiation of RCHT) neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3 platelets ≥100.000/mm3 hemoglobin ≥10g/dL BUN <1.5 times the upper range Total and direct bilirubin <1.5times the upper laboratory limit Adequate liver enzymes <3 times the upper laboratory limit Life expectancy >12 weeks Written informed consent Exclusion Criteria: refusal of the patients to take part in the study previous radiotherapy of the brain or chemotherapy with DTIC or TMZ known allergy against extrinsical proteins previous chemotherapy or therapy with an EGFR-inhibitor Previous antibody therapy Patients who have not yet recovered from acute toxicities of prior therapies Acute infections requiring systemic application of antibiotics Frequent vomiting or a medical condition preventing the oral application of TMZ Clinically active kidney- liver or cardiac disease Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) HIV Pregnant or lactating women Participation in another clinical study

Sites / Locations

  • University of HeidelbergRecruiting

Outcomes

Primary Outcome Measures

Toxicity

Secondary Outcome Measures

Overall survival

Full Information

First Posted
April 5, 2006
Last Updated
September 7, 2006
Sponsor
Heidelberg University
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00311857
Brief Title
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Official Title
Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

5. Study Description

Brief Summary
GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial. Primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Cetuximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Type
Procedure
Intervention Name(s)
Radiation therapy
Primary Outcome Measure Information:
Title
Toxicity
Secondary Outcome Measure Information:
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >= 18 and < 70 years of age Karnofsky Performance Score >= 60 histologically confirmed supratentorial GBM interval between primary diagnosis and registration for the study < 4 weeks patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3 adequate blood values (not older than 14 days prior to initiation of RCHT) neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3 platelets ≥100.000/mm3 hemoglobin ≥10g/dL BUN <1.5 times the upper range Total and direct bilirubin <1.5times the upper laboratory limit Adequate liver enzymes <3 times the upper laboratory limit Life expectancy >12 weeks Written informed consent Exclusion Criteria: refusal of the patients to take part in the study previous radiotherapy of the brain or chemotherapy with DTIC or TMZ known allergy against extrinsical proteins previous chemotherapy or therapy with an EGFR-inhibitor Previous antibody therapy Patients who have not yet recovered from acute toxicities of prior therapies Acute infections requiring systemic application of antibiotics Frequent vomiting or a medical condition preventing the oral application of TMZ Clinically active kidney- liver or cardiac disease Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) HIV Pregnant or lactating women Participation in another clinical study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Schulz-Ertner, MD
Phone
+49-6221-56
Ext
8201
Email
Daniela.Ertner@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie E Combs, MD
Phone
+49-6221-56
Ext
8201
Email
Stephanie.Combs@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Schulz-Ertner, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Schulz-Ertner, MD
Phone
+49-6221-56
Ext
8201
Email
Daniela.Ertner@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Stephanie E Combs, MD
Phone
+49-6221-56
Ext
8201
Email
Stephanie.Combs@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Daniela Schulz-Ertner, MD
First Name & Middle Initial & Last Name & Degree
Stephanie E Combs, MD

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)

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