Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412503
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2006-12-15
Brief Title:
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sarcomasneuroblastomas 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 mgm2d x 5 d and TPT 15 mgm2d 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None