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Can a Two-Drug combo outsmart childhood cancers that resist treatment?

NCT ID NCT00412503

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether combining two chemotherapy drugs, temozolomide and topotecan, is safe and tolerable for children and adolescents with malignant tumors that have returned or not responded to standard treatments. The study aims to find the highest safe dose of each drug when used together, while also checking how the body processes them and whether the combination shows any signs of shrinking tumors. Participants must have a confirmed cancer with no curative options available and be healthy enough to undergo treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of two chemotherapy drugs: temozolomide and topotecan
What this could lead to
If the combination proves safe and effective, it could offer a new treatment option for children with hard-to-treat cancers that have not responded to standard therapies.
What could go wrong
This is an early-phase trial focused on safety and dosing, so the combination may not work as hoped. There are also risks of side effects from the chemotherapy drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 21 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cancer neoplasm refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant tumors Refractory tumors

Contacts and locations

Locations

  • Institut Gustave Roussy

    Villejuif, Ille de France, 94805, France

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