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

Malignant Tumors Clinical Trial

Official title:

Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412503
• Other study ID #: CSET 1197
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2006
• Last updated: August 6, 2009

Study information

• Verified date: August 2009
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 6 Months to 21 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Tumors
• Neoplasms
• Refractory Tumors

Intervention

Drug:
• Topotecan, Temozolomide

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif	Ille de France

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- To determine MTD and DLT of each drug
Secondary	To assess safety profile
Secondary	To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
Secondary	To assess the efficacy of the association