Know Cancer

or
forgot password

A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases


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

Thank you

Trial Information

A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases


OBJECTIVES:

Primary

- Determine the 6-month and 1-year local control rate in patients with newly diagnosed
supratentorial brain metastases treated with brachytherapy using the intracavity
GliaSite^® Radiation Therapy System (RTS) after surgical resection.

Secondary

- Determine the overall survival of patients treated with this regimen.

- Determine distant brain recurrence in patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

- Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgical resection of the metastatic brain lesion(s) followed by
implantation of the GliaSite^® Radiation Therapy System (RTS). Beginning within the 21 days
after surgical resection, patients undergo brachytherapy using the GliaSite^® RTS over 3-7
days. Patients with tumor(s) remaining after surgery also undergo stereotactic radiosurgery
14-42 days after surgical resection and after completion of brachytherapy. Treatment
continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 1 and 3 months, and then every 3 months for 2
years.

Patients are followed at 1 and 3 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic carcinoma

- Stable systemic disease staged within the past 6 weeks

- No histology of lymphoma or small cell lung cancer

- Newly diagnosed supratentorial metastatic brain lesions

- One to three lesions with at least 1 dominant lesion that is amenable to
surgical resection as visualized on enhanced MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 6 months

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No uncontrolled hypertension

- No unstable angina pectoris

- No evidence of uncontrolled cardiac dysrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other serious infection or medical illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

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

- No prior temozolomide for brain metastasis

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent external-beam radiotherapy to the brain

- No concurrent whole-brain radiotherapy

Surgery

- Not specified

Other

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-month local control rate

Safety Issue:

No

Principal Investigator

Michael A. Vogelbaum, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000378193

NCT ID:

NCT00096252

Start Date:

December 2003

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