Phase II Cisplatin + Temozolomide in Malignant Glial Tumo... | NCT00147160

Studies
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

NCT00147160

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Apr 11, 2012Estimated

Enrollment

87Estimated

Phase

Phase 2

Conditions

Glioma

Interventions

Temozolomide, Cisplatinum

Countries

France
United Kingdom

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

ID	Type	Description	Link
CSET-2002/978

Status Module

Record Verification Date

Sep 2006

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

Oct 2003

Primary Completion Date

Jul 2006Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 7, 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

Apr 10, 2012

Last Update Posted Date

Apr 11, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents

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

87Estimated

Name	Type	Description	Arm Group Labels	Other Names
Temozolomide, Cisplatinum	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival
Health status and quality of life
Toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age from 4th birthday and younger than 21st birthday
Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
Measurable and evaluable disease by the imaging criteria (MRI)
Patient not previously treated by either of the two drugs

Exclusion Criteria:

Malignant brain stem tumours are excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Grill, MD, PhD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave-Roussy		Villejuif		94805	France
Bristol Royal Hospital for Children

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077204	Temozolomide
D002945	Cisplatin

Ancestor Terms

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided