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

Phase 1
1 Year
21 Years
Not Enrolling
Refractory Solid Tumors in Children

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) of irinotecan and rapamycin combination in children with refractory solid tumors.

Outcome Description:

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.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpitaux Universitaires de Strasbourg


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

February 2011

Completion Date:

August 2014

Related Keywords:

  • Refractory Solid Tumors in Children
  • Neoplasms