Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedAugust 7, 2009
August 1, 2009
December 15, 2006
August 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
- To determine MTD and DLT of each drug
Secondary Outcomes (3)
To assess safety profile
To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
To assess the efficacy of the association
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Gustave Roussy
Villejuif, Ille de France, 94805, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Herve Rubie, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Last Updated
August 7, 2009
Record last verified: 2009-08