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About
This study will seek to determine the safety and toxicity profile as well as the maximum tolerated dose of Helixor® M in patients with advanced solid tumors.
Full description
This study is a Phase I study that consists of two phases: a dose escalation phase and an expansion phase. The dose escalation phase will be used to evaluate the safety and toxicity of Helixor® M (mistletoe extract). An accelerated titration design (ATD) will be utilized to determine the MTD. The expansion phase will be used to obtain preliminary efficacy data about Helixor® M.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Any patients who have had any prior treatment with Mistletoe (injection or infusion) will not be eligible for this study.
Inclusion Criteria
Patients with advanced solid tumors and have received first line standard systemic therapy with chemotherapy, immunotherapy, hormonal therapy or other standard treatments for metastatic disease. Patients must either have progressed, are refractory, have stable disease and/or removed from therapy due to toxicities. Patients beyond first line therapy that do not meet criteria may be considered on a case by case basis and allowed at discretion of PI.
Patients with the presence of at least one measurable lesion as defined by RECIST 1.1 criteria for response assessment. Prostate cancer patients with bone disease only are eligible.
Age >18 years.
ECOG performance status 0-2
Life expectancy of greater than 3 months.
Patients must have normal organ and marrow function as defined below (without growth factor or transfusion support within 14 days prior to first dose of investigational product):
Female patient of childbearing potential has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.
Female patients enrolled in the study, who are not free from menses for >2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with Visit 1 through 28 days after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives. Spermicides alone are not an acceptable method of contraception.
-- Male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 28 days after the last dose of study therapy.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
Primary purpose
Allocation
Interventional model
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21 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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