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New drug cocktail shows promise for kids with resistant cancers

NCT ID NCT01282697

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a combination of two drugs—rapamycin and irinotecan—in 42 children and young adults (ages 1–21) with solid tumors that did not respond to standard treatments. The main goal was to find the safest dose and understand side effects. The approach aims to block blood vessel growth in tumors and stop their progression.

What this could mean

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

Active substance
rapamycin and irinotecan
What this could lead to
If this works, it could point toward a new treatment option for children with solid tumors that haven't responded to standard therapies.
What could go wrong
This is a very early phase I trial with only 42 children, focused on safety and dosing—not yet on effectiveness. The combination may cause significant side effects or fail to shrink tumors.

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.

Participants

42 people

The number who actually took part.

Started

Apr 2011

Finished

Feb 2013

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

1 year to 21 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: * Age \>= 1 year old and =\< 21 years old; * Refractory solid tumors, histologically proven at diagnosis (no additional biopsy needs to be performed for the purpose of the study); * Relapsed or refractory solid tumors after standard treatment or phase II, III-IV clinical trials treatment have failed; * Karnofsky or Lansky status \>= 70%; * Life expectancy \>= 8 weeks; * No chemotherapy / radiotherapy within 4 weeks before entry into the study; * Adequate biological parameters : * Absolute neutrophil count \>= 1.0 x 109/L; * Platelet count \>= 100 x 109/L; * Hemoglobin \>= 8 mg/dL; * Total bilirubine =\< 1.5 ULN; * Transaminases =\< 2.5 ULN (=\< 5 ULN in case of liver metastases); * Creatinine clearance (Cockroft) \>= 70 mL/min/1.73 m2; * Normal coagulation profile with prothrombin \>= 70%, TCA =\< 35 and fibrinogen \>= 2 g/L; * Patients with 1 to 3 previous therapeutic lines are eligible; * No current grade \>= 2 organ toxicity based on NCI-CTCAE version 3.0; * All patients with reproductive potential must have an effective method of birth control while on study; * Negative pregnancy test in females when indicated; * Informed written consent signed by patients or their parents or legal guardians; * Patient who was informed of the results of prior medical consultation; * Patient having a social insurance. Exclusion Criteria: * Patient with a constitutional anomaly of coagulation and/or of hemostasis (type hemophilia, von Willebrand disease, congenital clotting factor deficit, platelet disorder), exposing them to increased risk of bleeding; * Pre-treatment with a mTOR inhibitor; * Other simultaneous malignancy; * Concurrent administration of any other anti-tumour therapy; * Known hypersensitivity or contraindication to study drugs or ingredients; * Severe concomitant disease (e.g. infection disease); * Patient unable for medical follow-up; * Pregnancy and/or lactation; * Patient included in another clinical drug trial; * Patient taking drugs interfering with pharmacology of rapamycin and/or irinotecan (e.g. drugs interfering with CYP3A4); * Patient under judicial protection.

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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

  • CHU La Timone

    Marseille, 13005, France

  • CHU Mère-Enfants

    Nantes, 44093, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Hôpital des Enfants

    Toulouse, 31059, France

  • Hôpital des Enfants - Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67098, France

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Hémato-Oncologie Pédiatrique (IHOP)

    Lyon, 67008, France

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