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A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases


OBJECTIVES:

- 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, as demonstrated by absence of
growth on subsequent imaging studies for a 1-year period, in patients with primary
renal cell carcinoma, hepatic metastases, or other solid tumors.

OUTLINE: Patients are stratified according to disease (localized hepatic metastases vs
primary renal neoplasms vs solid tumors in other sites).

Patients undergo thermal ablation by radiofrequency energy under magnetic resonance
guidance. Thermal ablation continues until the entire tumor is treated. Treatment ceases
when the entire lesion has undergone necrosis or the zone of necrosis or significant heat
deposition approaches vital neurovascular structures.

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

PROJECTED ACCRUAL: A total of 28-39 patients will be accrued for this study within 22-36
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

John R. Haaga, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU2Y00

NCT ID:

NCT00006255

Start Date:

April 2000

Completion Date:

March 2005

Related Keywords:

  • Kidney Cancer
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • unspecified adult solid tumor, protocol specific
  • liver metastases
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065