spindle-cell bone-sarcoma patients in complete remission after surgery for second relapse. MedDRA version: 9.1 Level: LLT Classification code 10049067 Term: Spindle cell sarcoma
Conditions
Interventions
Product Code: Iscador P
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Viscum Album
Current Sponsor code: Iscador P
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
WELEDA AG DEUTSCHLAND
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included only if the following apply: - Patient (or his/her legal representative) has voluntarily given written informed consent. - Histological diagnosis of osteosarcoma or spindle cell sarcoma of bone (MFH, leiomyosarcoma, dedifferentiated chondrosarcoma, fibrosarcoma). - Free of disease after second relapse. - Age 10 years. - ECOG Performance Status 0-2. - Adequate bone marrow function defined as: o peripheral absolute neutrophils: >1500 o platelets: >o=100.000 - Laboratory parameters within the following limits: o Bilirubine: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Bone sarcomas of other histological type. - Missing staging criteria showing disease free condition. - Treatment with Etoposide or Viscum album prior to study entry. - Concomitant treatment with drugs with immunostimulant or immunosuppressive properties. - Co-morbidity with one of the following: diabetes mellitus, tuberculosis, cancer, HIV-infection/ AIDS, other severe systemic diseases as cardiac insufficiency, parasitosis or CrohnŽs disease. - Known hypersensitivity to mistletoe-containing products. - Women who are pregnant, lactating or not using adequate contraception. - Previous participation in this clinical trial earlier in study course. Participation in any other clinical trial currently or within the last month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1) To determine the effect of the standardised Viscum-album Extract (VA-E) Iscador P and of Etoposide on quality of life (EORTC QOL C30 in patients > o = 18 years, POQOL in patients <18 years) after treatment of 12 months in patients with high grade osteosarcoma and spindle-cell bone sarcoma free of disease after surgery for a second relapse. 2) To determine the safety and tolerability of the standardised Viscum-album Extract (VA-E) Iscador P compared to Etoposide after treatment of 12 months in patients with high grade osteosarcoma and spindle-cell bone sarcoma free of disease after surgery for a second relapse.;Main Objective: To determine the efficacy and safety of the standardised Viscum-album Extract (VA-E) Iscador P administered subcutaneously compared to Etoposide given orally in patients with high grade osteosarcoma and spindle-cell bone sarcoma free of disease after surgery for a second relapse.;Primary end point(s): Rate of PRDFS (post-relapse disease- free survival) after 12 months of treatment compared to a historical control | — |
Countries
Italy
Outcome results
None listed