Rhabdomyosarcoma
Conditions
Interventions
Patients will be randomized 1:1 between treatments. Standard arm will be VI:
combination of Vincristin ( intravenous day 1 and 8) and Irinotecan
(intravenous day 1 - 5). Intervention arm will be the
Sponsors
Centre Oscar Lambret
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
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 12 years of age) OR Lansky Play Score 70-100 % (for patients = 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is defined as the proportion of patients who had a documented complete or partial tumour response occurring after the first 2 cycles of treatment which must be confirmed by a follow-up objective tumour assessment obtained within 4-5 weeks after the initial documentation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints are defined as follows: - Duration of tumour response: the time from first documentation of objective tumour response to the first objective or clinical documentation of progression - Time to treatment failure: the time from the date of first treatment administration to the first documentation of tumour progression, discontinuation of study treatment before one year, or death, whichever occurs first - Time to tumor progression: the time from the date of first treatment administration to the date of first objective or clinical documentation of tumour progression or death due to any cause - Overall survival: the time from the date of first treatment administration to date of death | — |
Countries
Netherlands
Outcome results
None listed