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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGM.D. Anderson Children's Cancer Hospital
Houston, Texas, United States
RECRUITINGEvent Free Survival
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.
Time frame: 12-months post complete resection of all metastases
Quality of life post resection
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 frame: 12-months post complete resection of all metastases
Time to relapse
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.
Time frame: 12-months post complete resection of all metastases
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