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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01282697
• Date of registration: 12/11/2010
• Primary sponsor: University Hospital, Strasbourg, France
• Public title: Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors RAPIRI
• Scientific title: Phase I Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
• Date of first enrolment: February 2011
• Target sample size: 33
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01282697
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Natacha ENTZ-WERLE, MD, PhD

• Name: Natacha ENTZ-WERLE, MD, PhD
• Affiliation: Hôpitaux Universitaires de Strasbourg

Key inclusion & exclusion criteria

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.



Age minimum: 1 Year
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Refractory Solid Tumors in Children

Intervention(s)

Drug: Combined administration of irinotecan and rapamycin

Primary Outcome(s)

Characterize the pharmacokinetics of rapamycin and irinotecan during the first cycle of treatment. [Time Frame: Day1 + day8]

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

Secondary ID(s)

4791

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut Gustave Roussy