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A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

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Trial Information

A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis


OBJECTIVES:

Primary

- Determine the 1-year local control rate in patients undergoing resection of a solitary
brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.

Secondary

- Determine the survival of patients treated with this therapy.

- Determine distant recurrence of disease in patients treated with this therapy.

- Determine the toxicity of this therapy in these patients.

- Determine the quality of life of patients treated with this therapy.

OUTLINE: This is a nonrandomized study.

Patients undergo surgical resection of a brain metastasis. Patients then undergo
intraoperative radiotherapy using the INTRABEAM® system.

Quality of life is assessed at baseline and then every 3 months for 2 years.

Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3
months for 2 years.

PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan

- Resectable disease

- Histological evidence of metastatic carcinoma by intraoperative pathology

- No primary lymphoma, germ cell carcinoma, or small cell lung cancer

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 3 months

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No uncontrolled hypertension

- No unstable angina pectoris

- No uncontrolled dysrhythmias

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No serious infection

- No other medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for
brain metastasis

Endocrine therapy

- Not specified

Radiotherapy

- No prior brain radiotherapy of any kind, including local or whole brain external beam
radiotherapy, brachytherapy, or stereotactic radiosurgery

- No concurrent external beam radiotherapy to the brain

- Not planning adjuvant whole brain radiotherapy after study therapy

Surgery

- Not specified

Other

- No other prior conventional or investigational local or systemic agents for brain
metastasis

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local control rate as measured by MRI with contrast at 1 year

Safety Issue:

No

Principal Investigator

Robert Weil, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

Unspecified

Study ID:

CDR0000378144

NCT ID:

NCT00107367

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195