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RECRUITING
NCT05726383
PHASE2

Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

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.

Official title: MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Osteosarcoma After Resection Of Pulmonary Metastases

Key Details

Gender

All

Age Range

8 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-05-14

Completion Date

2027-05-11

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DRUG

Iscador*P

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.

Locations (2)

Hackensack University Medical Center

Hackensack, New Jersey, United States

M.D. Anderson Children's Cancer Hospital

Houston, Texas, United States