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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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
St. Rita's Medical CenterLima, Ohio  45801
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Harrington Cancer CenterAmarillo, Texas  79106
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Hackensack University Medical CenterHackensack, New Jersey  07601
Wesley Medical CenterWichita, Kansas  67214
Great Falls ClinicGreat Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
Banner Thunderbird Medical CenterPhoenix, Arizona  85306
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Veterans Affairs Medical Center - Kansas CityKansas City, Kansas  64128
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Munson Medical CenterTraverse City, Michigan  49684
St. Francis Medical CenterCape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Internal Medicine Associates of BozemanBozeman, Montana  59715
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mercy Medical Center Oncology UnitSpringfield, Ohio  45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Welch Cancer CenterSheridan, Wyoming  82801