RecruitingPhase 2NCT05726383

Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma

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

Sponsor

Hackensack Meridian Health

Enrollment

32 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Osteogenic Sarcoma Recurrent

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.

Eligibility

Min Age: 8 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mistletoe extract (Iscador P) as an immune-boosting therapy for young people with osteosarcoma (bone cancer) that has spread to the lungs and come back after surgery. Mistletoe has been used in some countries as a complementary cancer therapy. **You may be eligible if...** - You are between 8 and 30 years old - You have osteosarcoma that has relapsed in the lungs at least once - All visible lung tumors have been surgically removed, achieving remission - Your diagnosis has been confirmed by pathology **You may NOT be eligible if...** - Your cancer has also spread outside the lungs - Surgery could not remove all detectable cancer - You have significant organ problems that prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIscador*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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05726383