Refractory TumorsPhase 1NCT00412503
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
A Phase 1 study testing Topotecan, Temozolomide in people with Refractory Tumors and Malignant Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Refractory Tumors, Malignant Tumors
- What is being tested?
- Topotecan, Temozolomide
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
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.
- Conditions
- Refractory Tumors, Malignant Tumors
- Being tested
- Topotecan, Temozolomide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topotecan, TemozolomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory TumorsStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herve Rubie, MD, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412503
- Sponsor's protocol ID
- CSET 1197
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2006
- Last updated
- 19 Aug 2026
- Results posted
- No
Publications
Rubie H, Geoerger B, Frappaz D, Schmitt A, Leblond P, Ndiaye A, Aerts I, Le Deley MC, Gentet JC, Paci A, Chastagner P, Dias N, Djafari L, Pasquet M, Chatelut E, Landman-Parker J, Corradini N, Vassal G. Phase I study of topotecan in combination with temozolomide (TOTEM) in relapsed or refractory paediatric solid tumours. Eur J Cancer. 2010 Oct;46(15):2763-70. doi: 10.1016/j.ejca.2010.05.004. Epub 2010 Jun 16.
PubMed 20558056
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00412503
- Acronym / sponsor ID
- CSET 1197
- Conditions
- Refractory Tumors, Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- First posted
- 18 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topotecan, Temozolomide | Drug | – |
Primary outcome
- To determine MTD and DLT of each drug
3 secondary outcomes
To assess safety profile
To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
To assess the efficacy of the association
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 20558056Rubie H, Geoerger B, Frappaz D, Schmitt A, Leblond P, Ndiaye A, Aerts I, Le Deley MC, Gentet JC, Paci A, Chastagner P, Dias N, Djafari L, Pasquet M, Chatelut E, Landman-Parker J, Corradini N, Vassal G. Phase I study of topotecan in combination with temozolomide (TOTEM) in relapsed or refractory paediatric solid tumours. Eur J Cancer. 2010 Oct;46(15):2763-70. doi: 10.1016/j.ejca.2010.05.004. Epub 2010 Jun 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herve Rubie, MD study chair
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topotecan, Temozolomide in people with Refractory Tumors and Malignant Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- To determine MTD and DLT of each drug. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.