Completed

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

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What is being tested

Data Collection

Who is being recruted

Neoplasms

From 6 Months to 21 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorGustave Roussy, Cancer Campus, Grand Paris
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePhase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
NCT00412503
Principal SponsorGustave Roussy, Cancer Campus, Grand Paris
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 21 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Neoplasms

Criteria

6 inclusion criteria required to participate
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)
Show More Criteria
3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Institut Gustave Roussy

Villejuif, FranceOpen Institut Gustave Roussy in Google Maps
CompletedOne Study Center