Temozolomide in Association With Topotecan in Refractory... | NCT00412503

Studies
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

NCT00412503

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Aug 7, 2009Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Refractory Tumors
Malignant Tumors

Interventions

Topotecan, Temozolomide

Countries

France

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

Aug 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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 15, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 18, 2006Estimated

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

Aug 6, 2009

Last Update Posted Date

Aug 7, 2009Estimated

Description Module

Brief Summary

Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- To determine MTD and DLT of each drug

Secondary Outcomes

Measure	Description	Time Frame
To assess safety profile
To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
To assess the efficacy of the association

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically documented malignant tumor
refractory or relapsing after conventional treatments and for which there is no curative treatment available
life expectancy > 8 weeks
no significant co-morbidity (NCI-CTC < 2)
No organ toxicity
no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy

Exclusion Criteria:

Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds
Hypersensibility to Dacarbazine (DTIC)
Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

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
Herve Rubie, MD	University Hospital, Toulouse	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif	Ille de France	94805	France

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D019772	Topotecan
D000077204	Temozolomide

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D003606	Dacarbazine

Browse Leaves

Not provided

Browse Branches

Not provided