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Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas

Information source: Centre Oscar Lambret
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gliomas.

Intervention: Fluvastatine (Drug); Celebrex (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Centre Oscar Lambret

Official(s) and/or principal investigator(s):
Pierre LEBLOND, MD, Study Director, Affiliation: Centre Oscar Lambret
Nicolas ANDRE, MD, Study Director, Affiliation: Hôpital pour Enfants de " La Timone " AP-HM

Overall contact:
Pierre LEBLOND, MD, Phone: +33(0)3 20 29 59 56, Email: p.leblond@o-lambret.fr

Summary

Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary role. Unlike other sites, many of these tumors are not amenable to complete resection either because of anatomical location, and sometimes they only can be biopsied. A substantial number of children will have recurrences following resection or will experience progression following incomplete tumor removal or biopsy. Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins are known to increase the sensitivity of gliomas to anti-tumor agents. Their association could be administered for long periods, in the hope of much reduced risk of toxicities. This is a national, multicentric, interventional, open-label, non-comparative, and non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in combination with fixed-dose of Celebrex. This project involves 10 SFCE health centers accustomed to phase I / II studies(Société

Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French

Society for the Fight against Cancer and Leukemia in Children and Adolescents).

Clinical Details

Official title: Phase I Study of Fluvastatin-Celebrex Association in Children or Adults With Optico-chiasmatic Gliomas

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum tolerated dose (MTD) of Fluvastatine combined to a fixed-dose of Celebrex

Secondary outcome:

Safety

Efficacy

Progression-free

Potential interactions between the two drugs

Detailed description: Method : the total number of patients and the number of dose levels tested will depend upon the safety data that occurred in the previous level. A minimum of two patients will be included in each dose level. The second patient will be included after a sufficient time to assess the absence of dose-limiting toxicity in the first patient level, or within 3 weeks of treatment. The first cycle of the first patient must be monitored before proposing transition to the next level. Dose escalation : the safety data for each dose level will be reviewed and discussed before the transition to the next level. An IDMC will meet at the end the dose escalation step, and will decide the possibility of extending the study to 14 additional patients at a dose level set below the maximum tolerated dose.

Eligibility

Minimum age: 6 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically confirmed recurrent or progressive primary hypothalamic-chiasmatic low

grade glioma, and not warranting a biopsy or surgery

- Histologically confirmed recurrent or progressive primary hypothalamic-chiasmatic

high grade glioma, excepted brainstem gliomas

- Relapsed or refractory disease after at least 1 line adjuvant treatment including

radiation therapy, but not surgery

- Measurable lesions according to RANO criteria

- Age > 6 years and < 21 years old

- Lansky score > 70 or WHO score < 2 (neurological conditions associated with the

disease should not be taken into consideration)

- Haematological conditions: ANC > 1000/mm3 and platelets > 75000/mm3

- Creatinine < 1. 5 x normal for age or calculated clearance > 70 ml/mn/1. 73m2

- Hepatic function: Total bilirubin < 3 N and SGOT and SGPT < 4 N

- Muscle enzymes : CPK < 2 N

- No organ toxicity superior to grade 2 according to NCI-CTCAE v4. 0

- No allergy, hypersensibility to one of the compounds of the treatment

- Patients able to swallow capsules

- Life expectancy at least > 6 months

- Patient affiliated with a health insurance system

- Effective contraception for patients (male and female) with reproductive potential

throughout the treatment period

- Written informed consent of patient and/or parents/guardians prior to the study

participation Exclusion Criteria:

- Chemotherapy within 21 days before D1 of experimental treatment. This period may be

shortened in case of previous chemotherapy with vincristine (2 weeks), or extended in case of targeted therapies (4 weeks), or treatment by nitrosoureas (6 weeks)

- Radiotherapy within 6 months before D1 of experimental treatment

- Peptic ulcer disease, or gastrointestinal bleeding

- Known hypersensitivity to sulfonamides.

- History of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other

allergic-type reactions induced by acetylsalicylic acid or NSAIDs , including COX-2 inhibitors (cyclo-oxygenase- 2)

- Inflammatory bowel disease.

- Known congestive heart failure (NYHA II- IV)

- Ischemic proven, peripheral and/or history of arterial stroke (including transient

ischemic attack)

- Pregnancy or breast feeding woman

- Known allergy to experimental treatment

- Organ toxicity superior to grade 2 according to NCI-CTCAE v4. 0

- Active infection

- Pre-existing muscle pathology

- Unsuitable for medical follow-up (geographic, social or mental reasons)

Locations and Contacts

Pierre LEBLOND, MD, Phone: +33(0)3 20 29 59 56, Email: p.leblond@o-lambret.fr

Centre Hospitalier de Bordeaux - Hôpital des Enfants, Bordeaux 33076, France; Not yet recruiting
Céline ICHER, MD, Phone: +33(0)5 57 82 04 38, Email: celine.icher@chu-bordeaux.fr

Centre Oscar Lambret, Lille 59020, France; Recruiting
Pierre LEBLOND, MD, Phone: +33(0)03 20 29 59 56, Email: p.leblond@lambret.fr

Hôpital pour enfants La Timone, Marseille 13385, France; Not yet recruiting
André NICOLAS, MD, Phone: +33(0)4 91 38 68 28, Email: nicolas.andre@ap-hm.fr

Centre Hospitalier de Nantes - Hôpital Mère enfants, Nantes 44000, France; Not yet recruiting
Nadège CORRADINI, MD, Phone: +33(0)2 40 08 36 10, Email: nadege.corradini@chu-nantes.fr

Institut Curie, Paris 75005, France; Not yet recruiting
Isabelle AERTS, MD, Phone: +33(0)1 44 32 43 33, Email: isabelle.aerts@curie.net

Centre Hospitalier de Strasbourg, Strasbourg 67098, France; Not yet recruiting
Natacha ENTZ WERLE, MD, Phone: +33(0)3 88 12 80 94, Email: natacha.entz-werle@chru-strasbourg.fr

Centre Hospitalier de Purpan - Hôpital des Enfants, Toulouse 31026, France; Not yet recruiting
Anne-Isabelle BERTOZZI, MD, Phone: +33(0)5 34 55 86 13, Email: bertozzi.ai@chu-toulouse.fr

Centre Hospitalier de Nancy, Vandoeuvre-les-Nancy 54511, France; Not yet recruiting
Pascal CHASTAGNER, MD, Phone: +33(0)3 83 15 46 37, Email: p.chastagner@chu-nancy.fr

Institut Gustave Roussy, Villejuif 94805, France; Not yet recruiting
Cécile FAURE-CONTER, MD, Phone: +33(0)4 78 78 28 81, Email: cécile.conter@lyon.unicancer.fr

Additional Information

Starting date: May 2014
Last updated: July 21, 2014

Page last updated: August 23, 2015

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