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Neoplasms, Bone Tissue

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European Mistletoe

Each Iscador® P therapy begins with a dose finding phase related to the drug' immunogenicity. In this phase, gradually increasing doses are used to determine the optimum individual dose response of the patient and to prevent excessive toxicity. The Iscador® P will be administered three times per week by subcutaneous injections (M,W,F) into the subcutaneous tissue of the thigh or abdomen. Treatment is administered according to a series of escalating doses that are given each of the three days in a week for 7 doses. There are 3 different series (Series 0, 1, and 2) and there are 7 dose vials in each series. Once the patient has reached their maximum tolerated dosing series, that series is used as the treatment regimen for the remaining weeks to a total duration of 52 weeks (13 cycles) or until disease progression. Each cycle is 4 weeks.

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.

Iscador*P

Sherri Mayans, RN

Katharine Offer, MD

Karen Moody, MD

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.

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.

Iscador® P is to be injected subcutaneously (abdominal) 3 times/week. All patients will start with Series 0 (0.01mg, 0.01mg, 0.1mg, 0.1mg, 1mg, 1mg, 1mg). If tolerated, they will receive this series for 2 consecutive boxes (2 x 7 vials per box). This will then be followed by Series 1 (0.1mg, 0.1mg, 1mg, 1mg, 10mg, 10mg, 10mg), which will be administered for the following 2 consecutive boxes (2 x 7 vials per box). If tolerated, patients will proceed to Series 2 (1mg, 1mg, 10mg, 10mg, 20mg, 20mg 20mg), which will be continued through week 52 (13 cycles).

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.

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

To estimate the event free survival for pediatric, adolescent and young adult patients with relapsed pulmonary osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all metastases.

Quality of life assessed with the NIH PROMIS® measures based on the patien's age. The PROMIS® Pediatric Profile v2.0 - Profile-25 and Parent-Proxy will be used for children from age 8 up to 18 years of age. It includes 25 questions with a graded categorical 5-point response scale.

The PROMIS-29 Plus 2 Profile v2.1 for adults is a patient-reported measure of quality of life for adults. It includes 31 questions with a graded categorical 5-point response scale.

Both PROMIS scales have a mean score of 50 and a standard deviation (SD) of 10 in the general population.

Time to relapse in pediatric, adolescent, and young adult patients with relapsed pulmonary osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all metastases.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma	NCT05726383	Osteogenic Sarc...	Iscador*P	8 Years - 30 Years	Hackensack Meridian Health
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma	NCT05726383	Osteogenic Sarc...	Iscador*P	8 Years - 30 Years	Hackensack Meridian Health

**Spots Global Cancer Trial Database for iscador*p**

Every month we try and update this database with for iscador*p cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iscador*p

Every month we try and update this database with for iscador*p cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

**Spots Global Cancer Trial Database for iscador*p**

Every month we try and update this database with for iscador*p cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.