Combination of Vincristine and Irinotecan with or without Temozolomide (VI or VIT) in children and adults with refractory or relapsed rhabdomyosarcoma
- Conditions
- Topic: National Cancer Research NetworkSubtopic: SarcomaDisease: Soft TissueCancer
- Registration Number
- ISRCTN66172474
- Lead Sponsor
- Centre Oscar Lambret (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
Tumor characteristics:
1. Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma (new biopsy recommended)
2. Relapsed or refractory disease which has failed standard treatment approaches
3. Patients must have measurable disease defined as lesions that can be measured in three dimensions by medical imaging techniques such as computerised tomography (CT) or magnetic resonance imaging (MRI). Ascites, pleural fluid, bone marrow disease and lesions seen on Tc scintigraphy or positron emission tomography (PET) scan only are not considered measurable.
Patient characteristics:
1. Age > 6 months and < 50 years
2. Karnofsky performance status (PS) 70-100% (for patients > 12 years of age)
OR Lansky Play Score 70-100% (for patients = 12 years of age)
3. Life expectancy >= 12 weeks
4. Adequate bone marrow function :
4.1. Absolute neutrophil count >= 1000/mm3
4.2. Platelet count >= 100,000/mm3 (transfusion independent)
4.3. Hemoglobin >= 8.5 g/dL (transfusion allowed)
5. Adequate renal function
5.1. Serum creatinine < 1.5 X ULN for age
5.2. If serum creatinine > 1.5 ULN, creatinine clearance or radioisotope GFR) must be > 70 ml/min/1.73 m²
6. Adequate hepatic function :
6.1. Total bilirubin = 1.5 times upper limit of normal (ULN) for age, except if the patient is known to have Gilbert?s syndrome
6.2. ALT and AST < 2.5 X ULN for age
7. Negative pregnancy test in females with childbearing potential
8. Fertile patients must use effective contraception
9. No active > grade 2 diarrhea or uncontrolled infection
10. No other malignancy, including secondary malignancy
11. Patient affiliated with a health insurance system. Applicable for French patients only
12. Written informed consent of patient and/or parents/ guardians
Prior or concurrent therapy:
1. 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
2. At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea, 2 weeks for vincristine, vinorelbine, vinblastine and lowdose cyclophosphamide)
3. No concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, or carbamazepine
4. No concurrent administration of any of the following : rifampicin, voriconazole, itraconazole, ketoconazole, aprepitant
5. No prior irinotecan or temozolomide administration
6. Prior administration of vincristine is allowed
7. Concurrent palliative radiation therapy to sites allowed except for the main measurable target lesion
8. Prior allo- or autologous SCT allowed; Upper Age Limit 50 years ; Lower Age Limit 6 months
1. Inclusion criteria failure
2. Concomitant anticancer treatment
3. Know hypersensitivity to any component of study drugs or ingredients
4. Pregnancy or breast feeding
5. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
6. Neuromuscular disorders (e.g. Charcot-Marie Tooth disease)
7. Uncontrolled intercurrent illness or active infection
8. Unavailable for medical follow-up (geographic, social or mental reasons)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete or partial tumour response is assessed after the first 2 cycles of treatment which must be confirmed by a follow-up objective tumour assessment.
- Secondary Outcome Measures
Name Time Method <br> 1. Duration of response<br> 2. Time to tumour progression<br> 3. Time to treatment failure<br> 4. Overall survival and adverse event profile<br>