Spots Global Cancer Trial Database for Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
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Trial Identification
Brief Title: Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
Official Title: Phase I Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
Study ID: NCT01282697
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H么pital des Enfants - Groupe Hospitalier Pellegrin, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Institut H茅mato-Oncologie P茅diatrique (IHOP), Lyon, , France
CHU La Timone, Marseille, , France
CHU M猫re-Enfants, Nantes, , France
Institut Curie, Paris, , France
H么pitaux Universitaires de Strasbourg, Strasbourg, , France
H么pital des Enfants, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Natacha ENTZ-WERLE, MD, PhD
Affiliation: H么pitaux Universitaires de Strasbourg
Role: PRINCIPAL_INVESTIGATOR
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