Mt. Vernon,
Illinois
62864
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.
Study summary:
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.
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