| Eligibility |
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):
- WBC = 3,000/mcL
- Absolute neutrophil count = 1,000/mcL
- Platelets = 90,000/mcL
- Hemoglobin = 9.0 g/dL
- Total bilirubin = 1.5 X ULN (patients with diagnosed Gilbert's Syndrome will not
be excluded if their direct bilirubin is within normal institutional limits)
- AST(SGOT)/ALT(SGPT) = 2.5 X ULN
- Creatinine =1.5 x ULN OR creatinine clearance = 50 mL/min/1.73 m2
- 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
- Patient with a known history or evidence of brain metastases.
- Patients who have had chemotherapy, radiation, hormonal, or biological cancer therapy
within 28 days prior to the first dose of study drug excluding patients on long term
hormonal therapies who have been on a stable dose for at least 3 months.
- Patient is currently participating or has participated in a study of an
investigational agent or using an investigational device within 28 days of the first
dose of study drug.
- Patients who have had surgery within 28 days of dosing of investigational agent,
excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and
biliary stent placement.
- Patient is expected to require any other form of systemic or localized antineoplastic
therapy while on study.
- Patient who has had prior treatment with Mistletoe.
- Patients who have received systemic corticosteroids within 28 days prior to the first
dose of study drug. Note: Systemic steroid therapy is allowed for subjects on
replacement therapy as long as prednisone = 10 mg or its steroid equivalent.
- Patients who have received systemic NSAID therapy within 14 days prior to the first
dose of study drug.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Mistletoe.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
- Presence of = CTCAE grade 2 toxicity (except peripheral neuropathy and ototoxicity,
which are excluded if = CTCAE grade 3) due to prior cancer therapy.
- Autoimmune disease: Patients with a history of inflammatory bowel disease, including
ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients
with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic
progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
vasculitis [e.g., Wegener's Granulomatosis]); CNS or motor neuropathy considered of
autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple
sclerosis). History of Grave's disease on stable thyroid hormone replacement for at
least 1 year is allowed.
- Patients with a known history of HIV, hepatitis B, hepatitis C, or tuberculosis
infection. Patients with a history of cleared hepatitis C (undetectable viral loads)
are allowed.
- Women with a positive pregnancy test on enrollment or prior to investigational product
administration
- Women who are pregnant or breastfeeding.
- Sexually active fertile men not using effective birth control if their partners are of
child bearing potential.
- Patient is unwilling or unable to comply with study procedures.
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