Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
ConditionOsteogenic Sarcoma Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-30
SponsorHackensack Meridian Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 resected. Patients with positive microscopic margins will be eligible to enroll.
Pathological confirmation of metastases from at least one of the resected sites.
Disqualifiers
Another known malignancy other than osteosarcoma that is progressing or requires active treatment.
Any prior history of other cancer within the prior 5 years with the exception of adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ).
Active infection requiring systemic therapy.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Trial design
Design model
Single group
Treatments tested in this trial
Iscador*P
DrugIscador 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Treatment Arm - Iscador*PExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Event Free Survival
To estimate the event free survival for pediatric, adolescent and young adult patients with relapsed resectable osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all disease.
Time frame
12-months post complete resectionSecondary outcomes
1
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 resection2
Time to relapse
Time to relapse in pediatric, adolescent, and young adult patients with relapsed resectable osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all disease.
Time frame
12-months post complete resectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hackensack Meridian Health
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Iscador AG, Arlesheim, Switzerland.
Collaborator
Tackle Kids Cancer
Collaborator
Susan Zabransky Hughes Foundation
Collaborator
Source ClinicalTrials.gov