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OncoMatch/Clinical Trials/NCT05726383

Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma

Is NCT05726383 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Iscador*P for osteogenic sarcoma recurrent.

Phase 2RecruitingHackensack Meridian HealthNCT05726383Data as of May 2026

Treatment: Iscador*PThis 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.

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Extracted eligibility criteria

Cancer type

Osteosarcoma

Sarcoma

Disease stage

Metastatic disease required

Prior therapy

Must have received: surgical resection — 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

Cannot have received: systemic chemotherapy

Patients must have had no systemic chemotherapy or immunotherapy in the three weeks prior to enrollment

Cannot have received: immunotherapy

Patients must have had no systemic chemotherapy or immunotherapy in the three weeks prior to enrollment

Cannot have received: radiation therapy

Patients must not have received radiation therapy for up to two weeks prior to enrollment

Cannot have received: chemotherapeutic agent (conventional or experimental)

Patients may not receive any additional chemotherapeutic agent (either conventional or experimental) while on study

Lab requirements

Blood counts

Absolute neutrophil count ≥ 500/dL; Platelet count ≥ 20,000/L

Kidney function

Creatinine ≤ 1.5x ULN or calculated creatinine clearance (CrCl) ≥ 60 ml/minute

Liver function

AST and ALT ≤ 5x ULN; total bilirubin < 2.5x ULN or direct bilirubin ≤ ULN for patients with total bilirubin > 2.5x ULN

Adequate hepatic function with serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN) and total serum bilirubin < 2.5 times the ULN or Direct bilirubin ≤ ULN for patients with total bilirubin levels > 2.5 X ULN; Absolute neutrophil count ≥ 500/dL; Platelet count ≥ 20,000/L; Creatinine ≤ 1.5 X the ULN or measurement of calculated creatinine clearance (CrCl) ≥ 60 ml/minute

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Hackensack University Medical Center · Hackensack, New Jersey
  • M.D. Anderson Children's Cancer Hospital · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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