TREATMENT OF TUMORS THAT OCCURED AGAIN (NEUROBLASTOMA AND EWING´S SARCOMA) BASED ON HIGH DOSE CHEMOTHERAPY WITH TRANSPLANATION OF PATIENT'S PROPER CELLS
- Conditions
- Ewing's sarcoma, neuroblastomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002584-41-CZ
- Lead Sponsor
- Masarykova univerzita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
1.Signed written informed consent (participant and parents when required).
2.Age: less than 25 years at the time of enrolement.
3.Diagnosis: relapsed high-risk neuroblastoma (rNB) or relapsed Ewing´s sarcoma (rES).
a.Confirmation of rES or rNB by biopsy or cytology.
b.At least partial remission to reinduction chemotherapy (at least 2 cycles of conventional chemotherapy or 3 months of metronomic therapy) and/or local therapyb.
4.Performance status (Karnovsky/Lansky) = 40.
5.Renal, liver and cardiac functions not worse than grade III (CTC v4.0).
6.Negative pregnancy test in fertile women.
7.Stem cell product with a minimum of 2,0 x 106 CD34+/kg.
8.At least 28 days from the prior antitumour therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Performance status (Karnofsky/Lansky < 40).
2.Toxicity levels related to prior therapy preventing the HDCt application
3.Pregnancy or breastfeeding.
4.Patients taking part in a clinical trial testing another anticancer drug or a drug with a potential anticancer effect 14 days or less before the screening visit.
5.Confirmed allergy reaction to any of the study drug.
6.Patient with uncontrolled psychiatric disorder.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method