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Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma

NCT05726383 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Osteogenic Sarcoma Recurrent

Interventions

DRUG

Iscador*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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Iscador AG, Arlesheim, Switzerland.

    collaborator UNKNOWN

  • Tackle Kids Cancer

    collaborator UNKNOWN

  • Susan Zabransky Hughes Foundation

    collaborator UNKNOWN

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Katharine Offer, MD · Hackensack Meridian Health

  • Karen Moody, MD · MD Anderson

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2027-05-11
Completion
2027-05-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726383 on ClinicalTrials.gov