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A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up


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 periodically for 5 years after study entry.

PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected
disease will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

1-year

Safety Issue:

No

Principal Investigator

Jeffrey A. Sosman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065130

NCT ID:

NCT00002860

Start Date:

November 1996

Completion Date:

December 2010

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Kansas City Kansas City, Missouri  64131
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
St. Rita's Medical Center Lima, Ohio  45801
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Harrington Cancer Center Amarillo, Texas  79106
Dixie Regional Medical Center Saint George, Utah  84770
LDS Hospital Salt Lake City, Utah  84143
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Hackensack University Medical Center Hackensack, New Jersey  07601
Wesley Medical Center Wichita, Kansas  67214
Great Falls Clinic Great Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth Campus Grand Rapids, Michigan  49503-2560
Aultman Hospital Cancer Center at Aultman Health Foundation Canton, Ohio  44710-1799
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Banner Good Samaritan Medical Center Phoenix, Arizona  85006
Banner Thunderbird Medical Center Phoenix, Arizona  85306
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El Dorado El Dorado, Kansas  67042
Veterans Affairs Medical Center - Kansas City Kansas City, Kansas  64128
Cancer Center of Kansas - Kingman Kingman, Kansas  67068
Southwest Medical Center Liberal, Kansas  67901
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas, P.A. - Parsons Parsons, Kansas  67357
Pratt Cancer Center of Kansas Pratt, Kansas  67124
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, P.A. Wichita, Kansas  67208
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas, P.A. - Wichita Wichita, Kansas  67214
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Mecosta County General Hospital Big Rapids, Michigan  49307
Metropolitan Hospital Grand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical Center Grand Rapids, Michigan  49503
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Northern Michigan Hospital Petoskey, Michigan  49770
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Munson Medical Center Traverse City, Michigan  49684
St. Francis Medical Center Cape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Deaconess Billings Clinic Cancer Center Billings, Montana  59107
Internal Medicine Associates of Bozeman Bozeman, Montana  59715
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
Sletten Regional Cancer Institute Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Eastern Montana Cancer Center Miles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Fox Chase Virtua Health Cancer Program - Marlton Marlton, New Jersey  08053
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Mount Carmel West Hospital Columbus, Ohio  43222
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Mercy Medical Center Oncology Unit Springfield, Ohio  45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville, Ohio  43081
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Avera McKennan Hospital and University Health Center Sioux Falls, South Dakota  57105
Medical X-Ray Center Sioux Falls, South Dakota  57105
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Central Washington Hospital Wenatchee, Washington  98801
Wenatchee Valley Clinic Wenatchee, Washington  98801
Welch Cancer Center Sheridan, Wyoming  82801