Suspended

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

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What is being tested

stereotactic radiosurgery

Radiation
Who is being recruted

Brain Diseases+19

+ Central Nervous System Diseases

+ Neoplasms

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1999
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 31, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003911
Principal SponsorSWOG Cancer Research Network
Last updated: January 31, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplastic ProcessesNervous System DiseasesNervous System NeoplasmsPathologic ProcessesSkin DiseasesSkin NeoplasmsPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsBrain NeoplasmsMelanomaNeoplasm Metastasis

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)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 86 locations

MBCCOP - Gulf Coast

Mobile, United StatesOpen MBCCOP - Gulf Coast in Google Maps

CCOP - Greater Phoenix

Phoenix, United States

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, United States

Veterans Affairs Medical Center - Tucson

Tucson, United States
Suspended86 Study Centers