At a glance
ClinicalIndex Comparison Record- ✓Histologic diagnosis of osteosarcoma
- ✓At least one episode of relapse in the lung following surgical resection of all gross metastatic disease
- ✓Surgical resection of all possible sites of suspected pulmonary metastases to achieve complete remission within 8 weeks prior to enrollment
- ✓Pathological confirmation of metastases from at least one resected site
- ✕Another known malignancy (other than osteosarcoma) that is progressing or requires active treatment
- ✕Prior history of other cancer within 5 years (except basal cell carcinoma, CIN/cervical carcinoma in situ, or melanoma in situ)
- ✕Active infection requiring systemic therapy
- ✕Known active CNS metastases and/or carcinomatous meningitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Resectable Osteosarcoma
In Brief
A Phase 2 clinical trial evaluating Iscador*P for Osteogenic Sarcoma Recurrent. Currently recruiting, targeting 32 participants across 2 sites.
Detailed Summary
This will be a phase II, single arm study of osteosarcoma patients with fully resected pulmonary metastases. The MTD corresponds to the dosage recommendations of the manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany and Switzerland for the treatment of solid tumors and precancerous lesions. The study population includes patients with relapse of osteosarcoma in the lung following surgical resection of all gross disease (2nd or greater CR). Following completion of final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD with surveillance imaging via CT scan to monitor for relapsed disease.
Study Details
Timeline
Interventions
Iscador P given for 2 cycles with follow up imaging done every 2 cycles. If imaging is negative patient remains on study for 13 cycles. If new lesion is found, then patient is off study.