SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002860
• Other study ID #: CDR0000065130
• Secondary ID: U10CA032102SWOG-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 11, 2012
• Start date: November 1996
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2010
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Procedure:
• Surgery
Complete surgical resection of metastatic melanoma

Locations

Country	Name	City	State
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	Harrington Cancer Center	Amarillo	Texas
United States	American Fork Hospital	American Fork	Utah
United States	Alaska Regional Hospital Cancer Center	Anchorage	Alaska
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Joseph Hospital Community Cancer Center	Bellingham	Washington
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Mecosta County General Hospital	Big Rapids	Michigan
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Deaconess Billings Clinic Cancer Center	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare	Billings	Montana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Internal Medicine Associates of Bozeman	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	St. James Community Hospital	Butte	Montana
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	St. Francis Medical Center	Cape Girardeau	Missouri
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Riverside Cancer Services	Columbus	Ohio
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Mercy Medical Center	Grand Rapids	Michigan
United States	Metropolitan Hospital	Grand Rapids	Michigan
United States	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan
United States	Big Sky Oncology	Great Falls	Montana
United States	Great Falls Clinic	Great Falls	Montana
United States	Sletten Regional Cancer Institute	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	St. Peter's Hospital	Helena	Montana
United States	Holland Community Hospital	Holland	Michigan
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Borgess Medical Center	Kalamazooaa	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Kansas
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Southwest Medical Center	Liberal	Kansas
United States	St. Rita's Medical Center	Lima	Ohio
United States	Logan Regional Hospital	Logan	Utah
United States	McKee Medical Center	Loveland	Colorado
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Fox Chase Virtua Health Cancer Program - Marlton	Marlton	New Jersey
United States	Eastern Montana Cancer Center	Miles City	Montana
United States	Community Medical Center	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Good Samaritan Regional Health Center	Mt. Vernon	Illinois
United States	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Hackley Hospital	Muskegon	Michigan
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Banner Thunderbird Medical Center	Phoenix	Arizona
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Medical X-Ray Center	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Mercy Medical Center Oncology Unit	Springfield	Ohio
United States	Dixie Regional Medical Center	St. George	Utah
United States	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri
United States	David C. Pratt Cancer Center at St. John's Mercy	St. Louis	Missouri
United States	Munson Medical Center	Traverse City	Michigan
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Central Washington Hospital	Wenatchee	Washington
United States	Wenatchee Valley Clinic	Wenatchee	Washington
United States	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio
United States	Associates in Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas, P.A.	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Wesley Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sondak VK, Liu PY, Warneke J, et al.: Surgical resection for stage IV melanoma: a Southwest Oncology Group trial (S9430). [Abstract] J Clin Oncol 24 (Suppl 18): A-8019, 457s, 2006.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1-year	No