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A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

Phase 2
Not Enrolling
Melanoma (Skin), Metastatic Cancer

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Trial Information

A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

OBJECTIVES: I. Estimate the 6 month intracranial progression rate and 6 month overall
survival rate in patients with limited brain metastases from malignant melanoma undergoing
whole brain radiotherapy followed by stereotactic radiosurgery boost. II. Evaluate the
qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: Patients undergo whole brain radiotherapy 5 days a week for 3 weeks, followed 3-5
weeks later by stereotactic radiosurgery. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven malignant melanoma at primary or any
metastatic site Bidimensionally measurable disease by MRI scan Must have 1-6 enhancing
brain metastases If at least 2 lesions are present, only 1 lesion may be greater than 3 cm
in maximum diameter

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier or
immunotherapy Chemotherapy: No concurrent chemotherapy with whole brain radiotherapy Prior
systemic chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior
stereotactic or conventional radiotherapy to any field of the brain Surgery: Prior
surgical resection of brain metastases allowed (provided 1 or 2 measurable brain
metastases remain)

Type of Study:


Study Design:

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

Principal Investigator

James G. Douglas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

August 2007

Related Keywords:

  • Melanoma (Skin)
  • Metastatic Cancer
  • stage IV melanoma
  • recurrent melanoma
  • tumors metastatic to brain
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



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