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Clinical Trial: Surgery in Treating Patients With Metastatic Melanoma
This study is currently recruiting patients.
Purpose
RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with metastatic melanoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Stage IV Melanoma Recurrent Melanoma | Procedure: conventional surgery Procedure: surgery | Phase II |
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Complete Surgical Resection in Patients With Stage IV Melanoma
Further Study Details:
OBJECTIVES:
- Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease.
- Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state.
OUTLINE: This is a multicenter study.
All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431.
Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician.
Patients are followed every 3 months for 2 years and then every 6 months until recurrence.
PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable
- Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected
- Recurrence in iliac lymph nodes after inguinal lymph dissection allowed
- No metastatic disease beyond the lesions planned for resection
- Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study
- Concurrent registration on protocol SWOG-9431 required
PATIENT CHARACTERISTICS: Age:
- 18 and over
Performance status:
- SWOG 0-2
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free
- Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Prior immunotherapy in the adjuvant or metastatic setting allowed
Chemotherapy:
- Prior chemotherapy in the adjuvant or metastatic setting allowed
Endocrine therapy:
- Prior hormonal therapy in the adjuvant or metastatic setting allowed
Radiotherapy:
- Prior radiotherapy in the adjuvant or metastatic setting allowed
Surgery:
- See Disease Characteristics
- At least 14 days since prior surgery in the adjuvant or metastatic setting
Other:
- Recovered from prior therapy
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Thomas P. Miller, MD 520-626-2667
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Thomas Dale Kummet, MD 602-277-5551
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Harinder S. Garewal, MD 520-629-4686
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Laura Fulper Hutchins, MD 501-686-8511 LFHutchins@uams.edu
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
Bart Barlogie, MD 501-526-2873
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
Joseph Szumowski, MD 510-465-8570
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Ian C. Anderson, MD 707-521-3830
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
John L. Barstis, MD 310-825-5268
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
David R. Gandara, MD 916-734-3772 dgandara@cc.ucdmc.ucdavis.edu
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Heinz-Josef Lenz, MD 323-865-3955 lenz@usc.edu
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Mark E. Reeves, MD, PhD 909-583-6064
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
David R. Gandara, MD 925-372-2064
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Madeleine A. Kane, MD, PhD 303-399-8020 ext. 3129 madeleine.kane@med.va.gov
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Raoul R. Salup, MD 813-972-7579 raoul.salup@med.va.gov
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Thomas E. Seay, MD, PhD 404-851-2340
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
Patrick J. Stiff, MD 708-327-3148
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-569-6129
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Nirmala Bhoopalam, MD 708-202-2782
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Sarah A. Taylor, MD 913-588-6029 sataylor@kumc.edu
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Michael A. Doukas, MD 859-257-3379
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Michael A. Doukas, MD 859-281-4956
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
Glenn M. Mills, MD 318-675-5970 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
German S. Beltran, MD 504-588-5482
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Glenn M. Mills, MD 318-221-8411
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Douglas V. Faller, MD, PhD 617-638-4173
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Robert Anthony Chapman, MD 313-916-1332 rchapma1@hfhs.org
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
James Tate Thigpen, MD 601-362-4471
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Bethany G. Sleckman, MD 314-569-6573
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Paul J. Petruska, MD 314-268-5451 petruspj@slu.edu
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Patrick W. Cobb, MD 406-259-2245
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cheryl L. Willman, MD 505-272-5837
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
Cheryl L. Willman, MD 505-265-1711
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Daniel P. Petrylak, MD 212-305-1731 dpp5@columbia.edu
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Richard I. Fisher, MD 585-275-0842 richard_fisher@urmc.rochester.edu
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Amy D. Tiersten, MD 212-652-1916
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Howard M. Gross, MD 937-832-1093
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH 513-584-3830
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
George Thomas Budd, MD 216-444-6480
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Edward G. Mansour, MD 216-778-4394 emansour@metrohealth.org
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Albert F. Muhleman, MD 513-475-6537 albert.muhleman@med.va.gov
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Howard M. Gross, MD 937-268-6511
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Daniel J. Culkin, MD, FACS 405-271-6900 daniel-culkin@ouhsc.edu
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
Craig R. Nichols, MD 503-494-6346
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Christopher W. Ryan, MD 503-220-8262
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
Jeffrey Kent Giguere, MD 864-241-6251
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
James Dewitt Bearden, MD 864-560-7050
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Carolyn E. Reed, MD 843-792-9321 reedce@musc.edu
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Carolyn E. Reed, MD 843-789-7804
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Mohammad Jahanzeb, MD 901-722-0532
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Harvey B. Niell, MD 901-523-8990 ext. 5533
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
Mitchell A. Garrison, MD 210-916-3281 mitchell.garrison@cen.amedd.army.mil
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
James E. Clarkson, MD 806-359-4673 ext. 228 jclarkson@harringtoncc.org
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Scott Michael Lippman, MD, FACP 713-745-3672
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
Geoffrey R. Weiss, MD 210-567-4777 weiss@uthscsa.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Robert P. Whitehead, MD 409-772-1164 rpwhiteh@utmb.edu
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Stephen E. Wright, MD 806-359-4673 ext. 230
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Geoffrey R. Weiss, MD 210-617-5186
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Phalguni Mukhopadhyay, MD 254-778-4811 ext. 4809
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Wolfram Samlowski, MD 801-585-0255 wolfram.samlowski@hci.utah.edu
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Wolfram Samlowski, MD 801-582-1565 ext. 1272
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
Lauren Kenneth Colman, MD 253-403-5259 lauren.colman@multicare.org
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Andrew David Jacobs, MD 206-341-0446
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Saul E. Rivkin, MD 206-386-2441
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
William H. Schubach, MD 206-764-2265
Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Gerald K. Bayer, MD 920-433-8889
Study chairs or principal investigators
Jeffrey A. Sosman, MD, Study Chair, Vanderbilt-Ingram Cancer Center
John Munn Kirkwood, MD, Study Chair, University of Pittsburgh Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000065130; SWOG-9430; ECOG-S9430; NCT00002860
Record last reviewed: October 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002860
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: October 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002860
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Ileostomy, Colostomy and Ileoanal Reservoir Surgery (National Institute of Diabetes and Digestive and Kidney Diseases)
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