Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

Boston Scientific

Status and phase

Withdrawn

Phase 1

Conditions

Neoplasm Metastasis

Pain

Treatments

Procedure: Radiation

Procedure: Cryoablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01461252

CUC10-BNE01

Details and patient eligibility

About

This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.

Full description

Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy and radiation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney). Radiation therapy, also called radiotherapy, uses carefully targeted doses of high-energy radiation to kill cancer cells. Radiation is used to treat many kinds of cancer.

Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older
Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease (primary bone cancer is excluded)
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (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, MRI, or ultrasound (US) imaging
Tumors must be suitable for cryoablation
If the primary tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
Cryoablation should be performed within 14 days of baseline evaluations
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
Life expectancy ≥ 2 months
Platelet count >50,000/mm³ within 6 weeks of screening
INR (International Normalized Ratio) <1.5 within 6 weeks of screening
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
Clinically suitable for cryoablation therapy
Clinically suitable for radiation therapy

Exclusion criteria

Leukemia, lymphoma, and myeloma
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Has undergone prior ablation treatment of the index tumor
Has undergone prior radiation therapy of the index tumor < 3 weeks prior to screening
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina 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, bowel, or bladder
Surgery at the tumor site or surgery involving the cryoablation-treated tumor
Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
ANC (absolute neutrophil count) <1000 mm3 within 6 weeks of screening
Uncontrolled coagulopathy or bleeding disorders
Currently pregnant, nursing, or wishing to become pregnant during the study
Active, uncontrolled infection
Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
Concurrent participation in other experimental studies that could affect the primary endpoint