NCT00006255

Brief Summary

RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors. PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

4.9 years

First QC Date

September 11, 2000

Last Update Submit

June 9, 2010

Conditions

Kidney CancerMetastatic CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerunspecified adult solid tumor, protocol specificliver metastases

Outcome Measures

Primary Outcomes (1)

  • Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue.

    Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.

Interventions

radiofrequency ablationPROCEDURE

Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.

thermal ablation therapyPROCEDURE

Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of primary renal cell carcinoma, hepatic metastases, or other solid tumor meeting the following criteria: * Not amenable to curative or substantial palliative therapy OR * Failed chemotherapy or biological response modifier therapy OR * Unlikely to benefit from conventional chemotherapy * No more than 5 measurable metastatic masses in the liver * No greater than 5 cm in diameter * Other tumor sites allowed if location and size amenable to ablation therapy * Measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 4 months Hematopoietic: * Granulocyte count at least 1,000/mm\^3 * Hemoglobin at least 8.0 g/dL * Platelet count at least 100,000/mm\^3 * No untreated bleeding diathesis Hepatic: * PT no greater than 13.5 seconds * PT/PTT normal if prior warfarin or heparin use Renal: * Not specified Cardiovascular: * No implanted pacemaker, incompatible aneurysm clip, or other device that would preclude magnetic resonance imaging * No myocardial infarction within the past 6 weeks * No unstable angina Other: * Not pregnant or nursing * No serious active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 28 days since prior biological response modifier therapy Chemotherapy: * See Disease Characteristics * At least 28 days since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to study lesion Surgery: * Not specified Other: * At least 7 days since prior nonsteroidal antiinflammatory drugs or aspirin * At least 1 hour since prior heparin * No concurrent warfarin * No concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5056, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsNeoplasm MetastasisCarcinoma, Renal Cell

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • John R. Haaga, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

US(1)