Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

NCT01767935 | Terminated Results FDA Device

• 4 other identifiers: IRB00020528NCI-2012-02087P30CA012197CCCWFU 97212
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Bone Metastases; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (4)

• Pain Medication Level, Assessed by Changes in Narcotic Medication Usage

  Baseline to 24 weeks

• 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

• Number of Participants Who Survived

  Up to 24 weeks post-cryosurgery

Study Arms (1)

Treatment (cryosurgery and radiation therapy)

EXPERIMENTAL

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.

Procedure: cryosurgery; Radiation: radiation therapy; Procedure: quality-of-life assessment

Interventions

cryosurgery PROCEDURE

Undergo cryosurgery

Also known as: cryoablation, cryosurgical ablation

Treatment (cryosurgery and radiation therapy)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (cryosurgery and radiation therapy)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (cryosurgery and radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• Endocare, Inc.: collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Cryosurgery; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Dr. David Childs
• Organization: Wake Forest University Health Sciences

dchilds@wakehealth.edu

336-716-2471

Study Officials

• David Childs

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 15, 2013
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 14, 2018
• Results First Posted: December 13, 2017

Record last verified: 2018-10

Locations

US (1)