Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Jeffrey A. Sosman

Study Chair

John Munn Kirkwood

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002860
Information obtained from ClinicalTrials.gov on January 12, 2012

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