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

Gustave Roussy

Status and phase

Completed

Phase 1

Conditions

Refractory Tumors

Malignant Tumors

Treatments

Drug: Topotecan, Temozolomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00412503

CSET 1197

Details and patient eligibility

About

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.

Sex

All

Ages

6 months to 21 years old

Volunteers

No Healthy Volunteers

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