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

Phase 1

Completed

• Conditions: Refractory Tumors; Malignant Tumors

• Registration Number: NCT00412503
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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 available

Study Timeline

• Study First Submitted: 2006-12-15
• Study First Submitted QC: 2006-12-15
• Study First Posted: 2006-12-18
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
- To determine MTD and DLT of each drug

Secondary Outcome Measures

Name	Time	Method
To assess safety profile
To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
To assess the efficacy of the association

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, Ille de France, France