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Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors

NCT01282697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-22

No results posted yet for this study

Summary

Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and could, in some cases, stop its progression. This drug combination has already been tested in adult patients with refractory tumors and seems to give encouraging results with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when these drugs are administered separately and in a context different from that of refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the maximum dose at which these two molecules may be administered and to assess the safety of this new combination of drugs.

Conditions

  • Refractory Solid Tumors in Children

Interventions

DRUG

Combined administration of irinotecan and rapamycin

This phase I trial is a dose escalation study of irinotecan + rapamycin with a 3+3 statistical design.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Natacha ENTZ-WERLE, MD, PhD · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-22
Primary Completion
2013-02-20
Completion
2013-02-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282697 on ClinicalTrials.gov