A Phase I Dose Escalating Trial of Mistletoe Extract in Patients with Advanced Solid Tumors
Johns Hopkins Kimmel Cancer Center in Baltimore
To assess the safety and characterize the toxicity of Helixor® M mistletoe extract administered intravenous (IV) in patients with advanced solid tumors. To identify the maximum tolerated dose (MTD) To measure tumor marker kinetics in patients receiving treatment.
Patients 18 years and older with advanced solid tumors that are refractory to approved therapy and have had at least one line of systemic treatment with chemotherapy, immunotherapy, hormonal therapy, or other standard treatments for metastatic disease.Patients must have at least one measurable lesion as defined by RECIST study criteria.Good performance status, with life expectancy of greater than 3 months.Patients must have normal organ and marrow function as defined by study lab parameters.No pregnant or breast feeding females. All patients of child bearing potential must used study approved birth control measures.NO history or evidence of brain metastasis.NO chemotherapy or cancer directed therapy within 28 days prior to starting trial.NO surgeries or use of steroids within past 28 days.NO ongoing need for non steroidal medications or within 14 days of starting trial.NO history of allergy to mistletoe extract or prior use of mistletoe extract.No ongoing intercurrent illness or social situations that would limit compliance with study requirements.NO history of autoimmune disease, HIV, HEP B or C, TB.
Treatment will be administered on an outpatient basis.Helixor M (Mistletoe) to be given IV over 3 hours, 3x weekly. For more information: http://www.hopkinsmedicine.org/kimmel_cancer_center/research_clinical_trials/clinical_trials/mistletoe.html
03/05/2019 05:03 AM