MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Resectable Osteosarcoma
Hackensack Meridian Health
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.
Description
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 fol…
Eligibility
- Age range
- 8–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologic diagnosis of osteosarcoma. * Patients with at least one episode of relapse in the lung (without limitation of number of episodes), following surgical resection of all gross metastatic disease. * Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 8 weeks prior to study enrollment. Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were rese…
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 CenterHackensack, New Jersey
- M.D. Anderson Children's Cancer HospitalHouston, Texas