Actively Recruiting
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma
Led by Hackensack Meridian Health · Updated on 2026-02-10
32
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hackensack Meridian Health
Lead Sponsor
M
M.D. Anderson Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of osteosarcoma
- At least one lung relapse following surgical removal of all visible metastatic disease
- Complete resection of all suspected lung metastases within 8 weeks before enrollment
- Pathological confirmation of metastases from resected sites
- Age 8 years or older and under 30 years
- Ability to receive subcutaneous injections
- Karnofsky performance score 60% if older than 16 years or Lansky score 60% if 16 years or younger
- Negative pregnancy test for females of childbearing potential before starting treatment
- Agreement to use effective contraception during the study and for 120 days after last dose (both female and male participants)
- Life expectancy more than two months
- Recovery from side effects of prior cancer therapy to less than Grade 1 (except alopecia, cytopenia, or neuropathy)
- Adequate liver function with AST and ALT 6 5 times upper limit of normal and bilirubin below specified limits
- Absolute neutrophil count at least 500/dL
- Platelet count at least 20,000/L
- Creatinine 6 1.5 times upper limit of normal or creatinine clearance at least 60 ml/minute
You will not qualify if you...
- Other active malignancy requiring treatment or progressing (except certain treated skin or cervical cancers)
- Active infection requiring systemic therapy
- Known active brain metastases or carcinomatous meningitis
- New osteosarcoma recurrence outside the lungs
- Psychiatric or substance abuse disorders interfering with study participation
- Participation in another investigational study within 4 weeks before starting study drug
- Known HIV infection
- Active hepatitis B or hepatitis C infection (with exceptions for resolved infections)
- History of chronic granulomatous, autoimmune, or certain infectious diseases
- Pregnant or breastfeeding females
- Systemic chemotherapy or immunotherapy within 3 weeks before enrollment
- Concurrent chemotherapy during the study
- Radiation therapy within 2 weeks before enrollment
- Known allergy to Iscador4 P or related products
- Use of immunostimulant or immunosuppressive drugs during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
2
M.D. Anderson Children's Cancer Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Laura Goode, MS, RN, PCNS-BC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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