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

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ClinicalTrials.gov Identifier: NCT01282697
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : January 25, 2011
Last Update Posted : January 25, 2011
Information provided by:

November 12, 2010
January 25, 2011
January 25, 2011
February 2011
March 2013   (Final data collection date for primary outcome measure)
  • Determine the maximum tolerated dose (MTD) of irinotecan and rapamycin combination in children with refractory solid tumors. [ Time Frame: 28 days ]
    The Dose-Limiting Toxicity (DLT) of the drug combination is determined during the first cycle (J1 to J28) of treatment. MTD will be defined as the dose level immediately below the dose level at which 2 patients in a cohort of 3 to 6 patients will have experienced a DLT.
  • Characterize the pharmacokinetics of rapamycin and irinotecan during the first cycle of treatment. [ Time Frame: Day1 + day8 ]
    Pharmacokinetic parameters for rapamycin will be evaluated at days 1 and 8 of the first cycle of treatment. Pharmacokinetic parameters for irinotecan will be evaluated at day 1 of the first cycle of treatment. Pharmacokinetic profile will be modelized for each patient.
Same as current
No Changes Posted
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Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
Phase I Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Refractory Solid Tumors in Children
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.
Experimental: rapamycin+irinotecan at a given dose
Intervention: Drug: Combined administration of irinotecan and rapamycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
August 2014
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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Christine GEILLER, Direction de la Recherche Clinique et des Innovations - Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Natacha ENTZ-WERLE, MD, PhD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP