Status:
UNKNOWN
A Prospective Dose Finding Study of Iscador Infusion
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 w...
Detailed Description
This is a prospective open label dose finding study (phase I) of Iscador®P in patients with histological or cytological confirmed diagnosis of an advanced malignant disease during a therapy-free inter...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04376931
Start Date
December 1 2020
End Date
July 1 2023
Last Update
July 29 2020
Active Locations (1)
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1
Haemek MC
Afula, North, Israel