Know Cancer

or
forgot password

A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance


Phase 1/Phase 2
21 Years
N/A
Not Enrolling
Both
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance


OBJECTIVES:

- Determine the side effects of radiofrequency ablation in patients with bone metastases.

- Determine the effect of this regimen on pain in these patients.

- Determine the effect of this regimen on mood in these patients.

- Determine the effects of narcotic usage in patients treated with this regimen.

- Determine the relationship between laboratory and imaging features of this treatment
and the effects of the treatment in these patients.

OUTLINE: This is a multicenter study.

Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic
lesion over approximately 12 minutes.

Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3
months after treatment.

Patients are followed at 1 week and then at 1 and 3 months.

PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed malignant disease with a bone lesion that
appears to be metastatic disease by clinical and/or imaging techniques

- Persistent intractable pain from a solitary site of bone metastases (greater than 5
on pain scale of 0-10)

- Bone metastasis must be amenable to radiofrequency ablation using a percutaneous
CT-guided approach

- Bone metastasis must be no greater than 8 cm

- No tumor mass in contact with hollow viscera

- No primary musculoskeletal malignancies, lymphoma, or leukemia

- No spinal metastases that do not have an intact cortex between the mass and the
spinal canal and exiting nerve roots

- No tumor involving weight-bearing long bone of lower extremity or impending fracture

PATIENT CHARACTERISTICS:

Age:

- 21 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least 70,000/mm^3

- No uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with
fresh frozen plasma and platelets

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No pacemaker

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 14 days since prior chemotherapy for metastatic disease

- No concurrent systemic chemotherapy for metastatic disease during and for 14 days
after study therapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 30 days since prior radioisotopes for metastatic disease

- No concurrent systemic radioisotopes for metastatic disease

Surgery:

- No surgical stabilization of tumor site with metallic hardware

Other:

- Prior aspirin, nonsteroidal anti-inflammatory medications, antiplatelet medications,
or warfarin must be discontinued for an appropriate period of time prior to study
based on the drug's half-life and known antiplatelet activity (e.g., 7 days for
aspirin and 24 hours for ibuprofen)

- At least 24 hours since prior low molecular weight heparin

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Safety Issue:

Yes

Principal Investigator

Damian E. Dupuy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rhode Island Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000069012

NCT ID:

NCT00026247

Start Date:

November 2001

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • bone metastases
  • pain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Comprehensive Cancer Center at Rhode Island HospitalProvidence, Rhode Island  02903
Mallinckrodt Institute of Radiology at Washington University Medical CenterSt. Louis, Missouri  63110
Radiology Consultants, IncorporatedYoungstown, Ohio  44512