S9903: Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003911
First received: November 1, 1999
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic radiosurgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma.


Condition Intervention Phase
Melanoma (Skin)
Metastatic Cancer
Radiation: stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Enrollment: 2
Study Start Date: July 1999
Study Completion Date: August 2007
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003911

  Show 86 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: James G. Douglas, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003911     History of Changes
Other Study ID Numbers: CDR0000067090, S9903, U10CA032102
Study First Received: November 1, 1999
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage IV melanoma
recurrent melanoma
tumors metastatic to brain

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014