INTERNATIONAL RANDOMIZED PHASE II TRIAL OF THE COMBINATION OF VINCRISTINE AND IRINOTECAN WITH OR WITHOUT TEMOZOLOMIDE (VI OR VIT) IN CHILDREN AND ADULTS WITH REFRACTORY OR RELAPSED RHABDOMYOSARCOMA

Phase 2

Recruiting

Conditions: Rhabdomyosarcoma
10072990

Registration Number: NL-OMON47843

Lead Sponsor: Centre Oscar Lambret

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma
• Relapsed / progressive disease (previously shown respons to chemo-therapy)
• Measurable disease (defined as lesions that can be measured in 3 dimensions by medical imaging techniques such as CT or MRI).
• 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-, renal- and hepatic function (as defined in protocol)
• Fertile patients must use effective contraception
• Written informed consent of patient and/or parents/ guardians

Exclusion Criteria

• Other malignancy, including secondary malignancy
• Concomitant anti-cancer treatment
• 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 psychological reasons)
• Concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, or carbamazepine
• Concurrent administration of any of the following: rifampicin, voriconazole, itraco-nazole, ketoconazole, aprepitant
• Prior irinotecan or temozolomide administration
• Less then 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea, 2 weeks for vincristine, vinorelbine, vinblastine and low-dose cyclophosphamide)
• Less 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is defined as the proportion of patients who had<br /><br>a documented complete or partial tumour response occurring after the first 2<br /><br>cycles of treatment which must be confirmed by a follow-up objective tumour<br /><br>assessment obtained within 4-5 weeks after the initial documentation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints are defined as follows:<br /><br>- Duration of tumour response: the time from first documentation of objective<br /><br>tumour response to the first objective or clinical documentation of progression<br /><br>- Time to treatment failure: the time from the date of first treatment<br /><br>administration to the first documentation of tumour progression,<br /><br>discontinuation of study treatment before one year, or death, whichever occurs<br /><br>first<br /><br>- Time to tumor progression: the time from the date of first treatment<br /><br>administration to the date of first objective or clinical documentation of<br /><br>tumour progression or death due to any cause<br /><br>- Overall survival: the time from the date of first treatment administration to<br /><br>date of death</p><br>