S9903: Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00003911
Collaborator
National Cancer Institute (NCI) (NIH)
2
86
97
0
0
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
Study Start Date
:
Jul 1, 1999
Actual Primary Completion Date
:
Aug 1, 2002
Actual Study Completion Date
:
Aug 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36652 |
| 2 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
| 3 | Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona | United States | 85012 |
| 4 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
| 5 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
| 6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 7 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
| 8 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
| 9 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033-0800 |
| 10 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 11 | Beckman Research Institute, City of Hope | Los Angeles | California | United States | 91010 |
| 12 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
| 13 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
| 14 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 15 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
| 16 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
| 17 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 18 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
| 19 | University of Colorado Cancer Center | Denver | Colorado | United States | 80262 |
| 20 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 21 | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905-5650 |
| 22 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 23 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 24 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
| 25 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 26 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
| 27 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
| 28 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
| 29 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40511-1093 |
| 30 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 31 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 32 | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | United States | 70112 |
| 33 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
| 34 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
| 35 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 36 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
| 37 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
| 38 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0752 |
| 39 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
| 40 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 41 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 42 | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
| 43 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
| 44 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
| 45 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 46 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
| 47 | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi | United States | 39534-2576 |
| 48 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
| 49 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 50 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110-0250 |
| 51 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
| 52 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
| 53 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 54 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
| 55 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
| 56 | Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 57 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45219 |
| 58 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
| 59 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 60 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 61 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 62 | CCOP - Dayton | Kettering | Ohio | United States | 45429 |
| 63 | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | United States | 73104 |
| 64 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 65 | Oregon Cancer Institute at Oregon Health and Science University | Portland | Oregon | United States | 97201-3098 |
| 66 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
| 67 | CCOP - Columbia River Program | Portland | Oregon | United States | 97213 |
| 68 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 69 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 70 | Simmons Cancer Center - Dallas | Dallas | Texas | United States | 75235-9154 |
| 71 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
| 72 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0209 |
| 73 | Texas Tech University Health Science Center | Lubbock | Texas | United States | 79423 |
| 74 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78284-7811 |
| 75 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78284 |
| 76 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
| 77 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 78 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84132 |
| 79 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
| 80 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
| 81 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 82 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
| 83 | University of Washington Medical Center | Seattle | Washington | United States | 98195-6043 |
| 84 | University of Washington | Seattle | Washington | United States | 98195 |
| 85 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
| 86 | MultiCare Radiation Oncology | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: James G. Douglas, MD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003911
Other Study ID Numbers:
- CDR0000067090
- S9903
- U10CA032102
First Posted:
Apr 12, 2004
Last Update Posted:
Jan 31, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms: