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

Conditions

• Refractory Solid Tumors in Children

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Combined administration of irinotecan and rapamycin — DRUG
  This phase I trial is a dose escalation study of irinotecan + rapamycin with a 3+3 statistical design.

Study Details

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.

Key Dates

Start date

Apr 22, 2011

Status verified

Dec 2025

Primary completion

Feb 20, 2013

Completion

Feb 20, 2013

Study Design

Enrollment

42 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: rapamycin+irinotecan at a given dose

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) of irinotecan and rapamycin combination in children with refractory solid tumors. [ Time Frame: 28 days ]