Bone Metastases, Pain
Conditions
Brief summary
This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells
Detailed description
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.
Interventions
PROCEDUREcryosurgery
Undergo cryosurgery
RADIATIONradiation therapy
Undergo radiation therapy
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Endocare, Inc.
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI | 24 hours | Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Medication Level, Assessed by Changes in Narcotic Medication Usage | Baseline to 24 weeks | Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose. |
| Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 24 weeks | — |
| Pain After Cryosurgery, as Measured by the BPI | Up to 24 weeks | Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome |
| Number of Participants Who Survived | Up to 24 weeks post-cryosurgery | Count of participants that survived. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Cryosurgery and Radiation Therapy) 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.
cryosurgery: Undergo cryosurgery
radiation therapy: Undergo radiation therapy
quality-of-life assessment: Ancillary studies | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Treatment (Cryosurgery and Radiation Therapy) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Cryosurgery and Radiation Therapy) | Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI | 5 score on a scale |
Secondary
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Cryosurgery and Radiation Therapy) | Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | 0 events |
Secondary
Number of Participants Who Survived
Count of participants that survived.
Time frame: Up to 24 weeks post-cryosurgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Cryosurgery and Radiation Therapy) | Number of Participants Who Survived | 1 Participants |
Secondary
Pain After Cryosurgery, as Measured by the BPI
Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome
Time frame: Up to 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Cryosurgery and Radiation Therapy) | Pain After Cryosurgery, as Measured by the BPI | Least pain | 7 score on a scale |
| Treatment (Cryosurgery and Radiation Therapy) | Pain After Cryosurgery, as Measured by the BPI | Average Pain | 10 score on a scale |
| Treatment (Cryosurgery and Radiation Therapy) | Pain After Cryosurgery, as Measured by the BPI | Right now | 2 score on a scale |
Secondary
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Cryosurgery and Radiation Therapy) | Pain Medication Level, Assessed by Changes in Narcotic Medication Usage | 2 mg |