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Can a Two-Drug combo outsmart returning childhood cancers?

NCT ID NCT00918320

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing whether combining two chemotherapy drugs—temozolomide and topotecan—can help children with neuroblastoma, brain tumors, or other solid tumors that have come back or not responded to standard treatment. Participants receive temozolomide by mouth and topotecan by IV once daily for five days per cycle. The main goal is to see how often tumors shrink or disappear, while also tracking side effects and how long any benefit lasts.

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 (taken by mouth) and topotecan (given by IV infusion).
What this could lead to
If effective, this drug combination could offer a new treatment option for children with hard-to-treat or returning solid tumors, potentially slowing disease or shrinking tumors.
What could go wrong
This is an early-phase trial, so the combination may not work for all tumor types. Chemotherapy also carries risks like low blood counts, fatigue, and increased infection risk.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

129 people

The number who actually took part.

Start date

Jun 2009

Finished

Aug 2015

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 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis) * Relapsed or refractory tumors in which correct standard treatment approaches have failed * No more than 2 lines of prior chemotherapy * Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion. For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring. * Age at inclusion: 6 months to ≤ 20 years * Lansky play score ≥ 70% or ECOG performance status ≤ 1 * Life expectancy ≥ 3 months * Adequate organ function: Adequate haematological function: haemoglobin ≥ 80 g/l, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/l and platelets ≥ 75 x 109/l; Adequate renal function: normal creatinine related to patient's age: * 0 - 1 year: ≤ 40 µmol/L * 1 - 15 years: ≤ 65 µmol/L * 15 - 20 years: ≤ 110 µmol/L Adequate hepatic function: bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (AST, ALT ≤5xULN in case of liver metastases) * Wash-out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study. * Patients previously treated with only one of the 2 drugs are eligible. * Able to comply with scheduled follow-up and with management of toxicity. * All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged \> 12 years must have a negative pregnancy test within 7 days before study treatment. * Written informed consent from patient, parents or legal guardian. Exclusion Criteria: * Concurrent administration of any other anti-tumour therapy. * Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study. * History of allergic reaction to the compounds or their solvents. * History of allergic reaction to Dacarbazine (DITC). * Galactosemia, Glucose-galactose malabsorption or lactase deficiency. * Pregnant or breast feeding young women. * Presence of symptomatic brain metastases in patients with solid non-CNS tumors.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Institut Gustave Roussy

    Villejuif, 94805, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.