E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
spindle-cell bone-sarcoma patients in complete remission after surgery for second relapse. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049067 |
E.1.2 | Term | Spindle cell sarcoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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: <2 o Creatinine: <1.5 x upper limit of normal. - No other malignancy prior study entry and during follow up. - Last antineoplastic treatment received at least 30 days prior to study entry. - Female, pre-menopausal patients must provide negative pregnancy test within two weeks before study entry and are willing to apply an adequate birth-control method. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of PRDFS (post-relapse disease- free survival) after 12 months of treatment compared to a historical control |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |