Malignant Tumors, Refractory Tumors
Conditions
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.
Interventions
DRUGTopotecan, Temozolomide
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 21 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine MTD and DLT of each drug | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety profile | — |
| To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated | — |
| To assess the efficacy of the association | — |
Countries
France
Contacts
STUDY_CHAIRHerve Rubie, MD
University Hospital, Toulouse
Outcome results
None listed