Advanced Cancer Clinical Trial
Official title:
A Prospective Dose Finding Study of Iscador Infusion: Phase Ib Study With Prolonged Observation (ISINFULA)
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Haemek MC | Afula | North |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of dose-limiting toxicities | Maximum tolerated dose (MTD) of Iscador®P infusions, i.e. the dose eliciting dose-limiting toxicities (DLTs) in a maximum of 1 out of 6 patients treated at that dose.treated at that dose. | Subjects will be in this study for up to 58 weeks ( 4 weeks of treatment and follow-up for a maximum of 52 weeks if subjects are deemed to have continuous clinical benefit from the Iscador®P infusions. | |
Secondary | Quality of Life as Assessed Using Functional Assessment of Cancer Therapy - General (FACIT-G) | The FACIT-F evaluates quality of life using 5 categories: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and fatigue (FS). Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-General (FACIT-G; range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-Fatigue (FACIT-F) trial outcome index (TOI; range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants. | Baseline and prior to each infusion in phase I and monthly in the follow-up period.4 weeks and follow up period for a maximum of 52 weeks | |
Secondary | Incidence of adverse drug reactions (ADRs). | frequency of ADRs to intravenous mistletoe treatment will be measured during the study. | Subjects will be in this study for up to 58 weeks ( 4 weeks of treatment and follow-up for a maximum of 52 weeks if subjects are deemed to have continuous clinical benefit from the Iscador®P infusions. | |
Secondary | Tumor response | Evaluation of tumor response will be according to the RECIST criteria V1.1 | 4 weeks and follow up period for a maximum of 52 weeks | |
Secondary | Progression-free survival | Time to disease progression will be defined as the time from first infusion of Iscador®P to the date of documentation of disease progression. | 4 weeks and follow up period for a maximum of 52 weeks | |
Secondary | Overall survival | Overall survival will be measured from the date of first infusion of Iscador®P until the date of the last follow-up or death. | 4 weeks and follow up period for a maximum of 52 weeks |
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