A Prospective Dose Finding Study of Iscador Infusion

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, dose-escalating mono-center open label dose-finding study without control group (3+3 design), including a follow-up on-treatment observation. In this study will be recruited 15 patients with a histologically or cytologically confirmed diagnosis of an advanced malignant disease during a therapy-free interval.Investigational drug:Iscador®P: fermented aqueous extract of mistletoe grown on pine tree (Viscum album L. subspecies austriacum (Wiesb.) Vollmann), licensed for subcutaneous (SC) application in Switzerland, Germany, Austria, Sweden, and South Korea in dosages up to 20 mg.

The initial dose group of the study is set to 40 mg Iscador®P.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HaEmek Medical Center, Israel

Criteria

Inclusion Criteria:

• Voluntarily given written informed consent.

• ≥18 years of age.

• Metastatic or locally advanced solid tumor, histologically or cytologically confirmed, no standard therapy available or standard therapy has failed.

• Adequate organ function

• Life expectancy ≥ 3 months, ECOG ≤ 2.

• No ongoing or preceding therapy with mistletoe products.

• Women of childbearing potential: negative serum pregnancy test at screening, use of two adequate barrier methods

• Compliance with protocol, legal competence.

Exclusion Criteria:

• - Systemic cytotoxic chemotherapy, biological therapy, radiation therapy, OR major surgery prior trial treatment.

• Persisting toxicity of NCI-CTCAE Grade >1 related to prior therapy (Sensory neuropathy of Grade ≤2 is acceptable).

• Expected to require any other form of systemic or localized antineoplastic therapy while on trial

• Systemic corticosteroid therapy received ≤ 3 days prior to trial treatment or other forms of systemic immunosuppressive medication (except corticosteroids against immune-related AEs and /or premedication for IV contrast allergies/reactions; corticosteroid replacement therapy)

• Tumor and/or metastases of the CNS and/or carcinomatous meningitis

• Active infection requiring intravenous systemic therapy, HIV, severe allergic illness (including asthma), active tuberculosis, inflammatory diseases with body temperature > 38° C.

• Known hypersensitivity to mistletoe products.