Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

PRIMARY OBJECTIVES:

I. To assess the potential for efficacy and safety of combining percutaneous computed
tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous
metastases.

OUTLINE:

Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15
fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4,
12, 18, and 24.

Inclusion Criteria:

- Pathologically (histologically or cytologically) confirmed metastatic disease with a
new tumor involving or abutting bone that has the clinical and imaging features of
metastatic disease

- If the nature of the metastatic disease has been previously documented, index
tumor to be treated does not require further documentation (i.e., biopsy)

- Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief
Pain Inventory [BPI], despite analgesic therapy) OR the subject is experiencing
intolerable side effects that preclude analgesic use (resulting in pain of 4 or above,
as measured by BPI)

- Pain must be from one or two painful metastatic sites in the bone (additional less
painful metastatic sites may be present)

- Pain from the reported one or two metastatic sites must correlate with an
identifiable tumor on CT, magnetic resonance imaging (MRI), or ultrasound (US)
imaging

- Metastatic tumors must be amenable to cryoablation with CT or MRI

- If the index tumor is in the spine, there must be an intact cortex between the mass
and the spinal canal and exiting nerve roots

- Patients must have stable use of hormonal therapy for two weeks prior to study
registration and two weeks prior to cryoablation procedure)

- Stable use of pain medications (no changes within two weeks of cryoablation procedure)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Life expectancy >= 2 months

- Platelets > 50,000/mm^3

- International normalized ratio (INR) >= 1.5

- Patients may not have any debilitating medical or psychiatric illness that would
preclude giving informed consent or receiving optimal treatment and follow-up

- Patients who are taking antiplatelet or anticoagulation medication (e.g., aspirin,
ibuprofen, low molecular weight heparin [LMWH] preparations) must be able to
discontinue such treatment prior to the cryoablation procedure for an appropriate
amount of time; at least 5 days should be allowed after discontinuation of aspirin,
Coumadin, clopidogrel, and dipyridamole; at least 12 hours should be allowed after
discontinuation of LMWH preparations

- Patients must be clinically suitable for cryoablation therapy

- Patients must be clinically suitable for radiation therapy

- Patients must be able to understand and willing to sign a written informed consent
document

Exclusion Criteria:

- Patients with a diagnosis of leukemia, lymphoma, or myeloma

- Patients with a tumor involving a weight-bearing long bone of the lower extremity with
the tumor causing > 50% loss of cortical bone

- Patients who have undergone prior ablation treatment or radiation therapy of the index
tumor

- Patients who have received chemotherapy within 14 days prior to and 14 days after
cryoablation procedure

- Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda
equine compression/effacement

- Anticipated treatment of the index tumor that would require iceball formation within
1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal
vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder

- Any prior surgery at the proposed treatment site OR any prior surgery involving the
cryoablation-treated tumor

- Index tumor involves the skull (treatment of other painful tumors in subjects with
skull tumors is not excluded)

- Patients with uncontrolled coagulopathy or bleeding disorders

- Patients who are pregnant, nursing, or who wish to become pregnant during the study

- Patients with active, uncontrolled infection

- Patients with serious medical illnesses, including any of the following: uncontrolled
congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular
event within six months prior to study entry

- Patients who are concurrently participating in any other experimental studies that
could affect the primary endpoint of this study