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Phase II trial opens for Viscum album extract adjuvant therapy in relapsed osteosarcomaEarly study explores mistletoe extract as additional treatment for relapsed bone cancer in young people

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Key Takeaway
Note: Phase II trial is open; pilot data (55% PREFS-12 in 9 patients) is preliminary.

A Phase II trial has been opened to investigate Viscum album extract (Iscador® P) as adjuvant therapy for children, adolescents, and young adults (AYAs) with relapsed, resectable osteosarcoma. The primary outcome is post-relapse event-free survival at 12 months (PREFS-12). Secondary outcomes include effects on quality of life and changes in immune profiling of tumor and serum samples. The trial's sample size, comparator, and follow-up duration are not reported.

Results from a prior pilot study, referenced in the trial description, involved 9 pediatric and AYA patients. In that small cohort, the 12-month post-relapse event-free survival rate was 55%, with a median follow-up of 84 months. No effect size, p-values, or confidence intervals for this finding are reported. Safety and tolerability data for the extract in this population are not reported.

Key limitations are significant. The main finding of 55% PREFS-12 comes from a small, uncontrolled pilot study, not the newly opened Phase II trial. The trial itself has not yet generated results. The absence of reported safety data, comparator details, and statistical measures for the pilot finding limits interpretation. The practice relevance of Viscum album extract in this setting remains highly uncertain and awaits data from the controlled Phase II investigation.

Doctors are conducting a Phase II trial to see if a treatment made from mistletoe extract (Iscador P) can help children, teens, and young adults with a type of bone cancer called osteosarcoma that has come back after initial treatment. The study is for patients whose cancer has returned but can still be surgically removed. The goal is to see if adding this extract after surgery helps keep the cancer from coming back again.

To get an early idea, researchers looked back at a small pilot study with just 9 young patients. In that small group, 55% were alive without their cancer getting worse one year after their relapse. The study also plans to check if the treatment affects patients' quality of life and their immune system's response.

It is very important to understand that this 55% result comes from a tiny, preliminary study. The new, larger Phase II trial has just started, so we do not have its results yet. This means we cannot say if the mistletoe extract is truly effective or safe for this use. The findings are a first step that needs much more research to confirm.

For now, this research represents an early scientific question being explored. Patients and families should know that this is not a proven treatment. The main takeaway is that researchers are investigating new options, but it will be a long time before anyone knows if this approach works.

What this means for you:
A mistletoe extract is being studied for relapsed bone cancer in young people, but it is not yet a proven treatment.

Study Details

Study typePhase2
EvidenceLevel 3
Follow-up12.0 mo
PublishedApr 2026
View Original Abstract ↓
Relapsed resectable osteosarcoma carries a dismal prognosis of 30% 12-month post-relapse event-free survival (PREFS-12). Surgery remains the primary therapy for metastatic pulmonary osteosarcoma with the role for adjuvant therapy still undefined. There is an urgent need for effective nontoxic adjuvant therapies to improve PREFS following complete resection of metastases. extract (Iscador® P, Iscador AG, Arlesheim, Switzerland) is a fermented aqueous extract manufactured from the leaves, stems, and berries of the white-berried hemiparasitic plant from the European mistletoe ( L.) grown on pine trees (P = Pini). It is a promising therapeutic antineoplastic agent with preclinical and clinical evidence of benefit in osteosarcoma. This includes a pilot study showing 55% PREFS in 9 pediatric, adolescent and young adult (AYA) patients with a median follow-up of 84 months. extract has a long history of use in Europe and a track record of safety in children which allowed for the opening of a Phase II trial in the US to test the efficacy of extract to improve PREFS in children and AYAs with relapsed osteosarcoma. Secondary outcomes include effects on quality of life and changes in immune profiling of tumor and serum samples.
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