VIT-0910

• Conditions: Rhabdomyosarcoma; MedDRA version: 18.1Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-023135-42-GB
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-27
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

TUMOUR CHARACTERISTICS:
•Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma (new biopsy recommended)
•Relapsed disease which has failed standard treatment approaches
•Patients must have measurable disease defined as lesions that can be measured in 3 dimensions by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease alone and lesions seen on Tc scintigraphy or PET scan only are not considered measurable.

PATIENT CHARACTERISTICS:
•Age > 6 months and < 50 years
•Karnofsky performance status (PS) 70-100% (for patients > 12 years of age)
OR Lansky Play Score 70-100 % (for patients = 12 years of age)
•Life expectancy = 12 weeks
•Adequate bone marrow function :
oAbsolute neutrophil count = 1000/mm3
oPlatelet count = 100,000/mm3 (transfusion independent)
oHemoglobin = 8.5 g/dL (transfusion allowed)
o In case of bone marrow disease:
o Absolute neutrophil count = 500/mm3
o Platelet count = 75,000/mm3
•Adequate renal function
oSerum creatinine < 1.5 X ULN for age
oIf serum creatinine > 1.5 ULN, creatinine clearance or radioisotope GFR) must be > 70 ml/min/1.73 m²
•Adequate hepatic function :
oTotal bilirubin = 1.5 times upper limit of normal (ULN) for age, except if the patient is known to have Gilbert’s syndrome
oALT and AST < 2.5 X ULN for age
•Negative pregnancy test in females with childbearing potential
•Fertile patients must use effective contraception
•No active > grade 2 diarrhea or uncontrolled infection
•No other malignancy, including secondary malignancy
•Patient affiliated with a health insurance system. Applicable for French patients only
•Written informed consent of patient and/or parents/ guardians

PRIOR OR CONCURRENT THERAPY:
•More than 3 weeks since prior radiation therapy to the site of any progressive lesion that will be identified as a target lesion to measure tumor response
•At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea, 2 weeks for vincristine, vinorelbine, vinblastine and low-dose cyclophosphamide)
•No concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, or carbamazepine
•No concurrent administration of any of the following : rifampicin, voriconazole, itraco-nazole, ketoconazole, aprepitant
•No prior irinotecan or temozolomide administration
•Prior administration of vincristine is allowed
•Concurrent palliative radiation therapy to sites allowed except for the main measurable target lesion
•Prior allo- or autologous SCT allowed

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Inclusion criteria failure
•Concomitant anticancer treatment
•Know hypersensitivity to any component of study drugs or ingredients
•Pregnancy or breast feeding
•Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
•Neuromuscular disorders (e.g. Charcot-Marie Tooth disease)
•Uncontrolled intercurrent illness or active infection
•Unavailable for medical follow-up (geographic, social or mental reasons)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified