| Eligibility |
Inclusion Criteria:
- Participants must meet the following criteria on screening examination to be eligible
to participate in the study:
- Participants must have histologically confirmed malignant tumor that is metastatic or
unresectable and for which standard curative or palliative measures do not exist or
are no longer effective.
- Participants with malignant locally recurrent and/or metastatic tumors will be
eligible for cryoablation. All tumor shapes and sizes will be eligible for ablation.
- Participants must have sustained all available treatment options (radiation,
chemotherapy, surgery) as verified by the Dana Farber Cancer Institute's Head and Neck
Tumor Board. These cases will be reviewed by a team of medical oncologists,
radiologists, radiation oncologists, and surgical oncologists.
- Participants must have an advanced head, neck or spine malignant tumor that would
potentially benefit from a minimally invasive procedure.
- Age 18 years or older
-- Because no dosing or adverse event data are currently available on the use of
cryoablation in participants < 18 years of age, children are excluded from this study
but will be eligible for future pediatric III trials.
- Life expectancy of greater than 8 weeks in the opinion of the referring clinician.
- Eastern Cooperative Oncology Group (ECOG) performance status = 2 (see Appendix A).
- Participants must have normal organ and marrow function as defined below:
- Leukocytes = 3,000/microliter (mcL)
- Absolute neutrophil count = 1,500/mcL
- Platelets = 100,000/microliter (mcL)
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) = 2.5 X
institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance = 60
mL/min/1.73 m2 for subjects with creatinine levels about institutional normal .
- Cryoablation can be performed near vessels of the head and neck, and if deemed
necessary tumor may be displaced using a saline injection (hydro-displacement). Tumor
displacement from nerves may be required and will be performed as deemed appropriate
to avoid nerve injury.
- The effects of cryoablation on the developing human fetus are unknown. For this reason
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- MRI-Guided Cryoablation Criteria-Cohort 1
-- Participants must have a mass that is well-visualized under MRI. Since positron
emission tomography-computed tomography (PET-CT) guidance requires the nuclear
medicine department to administer a radionuclide material, the default will be to try
to use MRI guidance.
- PET/CT-Guided Cryoablation Criteria-Cohort 2 -- Patients must have a mass that is well
visualized under PET/CT. Tumors that are not clearly seen by MRI but showing on PET/CT
will be ablated with PET/CT guidance.
Exclusion Criteria:
- Participants who exhibit any of the following conditions at screening will not be
eligible for admission into the study.
- Participants with tumors involving the optic chiasm, brain, or spinal cord will not be
eligible for participation in this study. Furthermore, tumors that encase any major
blood vessel (carotid, jugular, vertebral) will be excluded from the study due to
inability to displace these masses.
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants may not be receiving any other study agents.
- Participants with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gadolinium contrast agents, if contrast use is anticipated during the
procedure.
- Participants with a blood glucose level of > 200mg/dl prior to the baseline study,
known ischemic disease, and/or impaired renal function (eGFR < 60ml/min) will not be
eligible for this study.
- 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.
- Pregnant women are excluded from this study because gadolinium is a contrast agent
with the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk of adverse events in nursing infants secondary to treatment
of the mother with gadolinium, breastfeeding should be discontinued if the mother is
treated with gadolinium.
- MRI-Guided Cryoablation Exclusion Criteria-Cohort 1
- -Pregnant women are excluded from this study because gadolinium is a contrast agent
with the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk of adverse events in nursing infants secondary to treatment
of the mother with gadolinium, breastfeeding should be discontinued if the mother is
treated with gadolinium.
- PET/CT-Guided Cryoablation Exclusion Criteria-Cohort 2
- Based on potential risks of fetal loss, teratogenicity, fetal growth retardation
and carcinogenesis, PET/CT is contraindicated in the pregnant patient.
- Pregnant women are excluded from this study because PET/CT utilizes a radioactive
diagnostic agent with the potential for teratogenic or abortifacient effects.
Because there is an unknown but potential risk of adverse events in nursing
infants secondary to treatment of the mother with a radionclide, breastfeeding
should be discontinued if the mother is treated.
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