Stage IV Surgery Versus Best Medical Therapy (STG4SURG)
Stage IV Resectable Melanoma

About this trial
This is an interventional treatment trial for Stage IV Resectable Melanoma focused on measuring melanoma, stage IV, resectable, surgery, medical therapy
Eligibility Criteria
Inclusion Criteria:
- Patients must provide informed written consent for participation.
- At least 18 years of age
- Have a minimum life expectancy (excluding melanoma) of 5 years.
- All known disease must be surgically resectable in the opinion of a participating surgeon.
- Must have a histologic diagnosis of Stage IV melanoma arising from a primary cutaneous site or visceral metastasis from an unknown primary site and be within 4 months of initial stage IV diagnosis.
- Up to 3 visceral organs involved
- Up to 6 lesions allowed
- Must have ECOG performance status of 0 or 1.
- Must be in good general health with no serious co-morbid illness. Good clinical judgment must be exercised in careful selection of patients who are candidates for surgical resection of distant metastases.
Laboratory values within 30 days of randomization:
- WBC >3,000/mm3
- Lymphocytes >800/mm3
- Platelets >100,000/mm3
- Creatinine <2.0 mg/dL
- Bilirubin <2.0 mg/dL
- Alkaline phosphatase < 2X upper limit of normal (ULN)
- SGOT < 2X ULN
- SGPT < 2X ULN
- LDH < 1.5X ULN
Exclusion Criteria:
- Unresectable metastatic disease or more than 4 months since stage IV diagnosis.
- Brain or bone metastatic sites.
- History of primary uveal or mucosal melanoma.
- Another concomitant diagnosis that limits life expectancy to less than 5 years.
- Chronic immunosuppression due to inherited, acquired or iatrogenic immune defect. This includes active HIV, hepatitis, or use of immunosuppressive medications as a component of anti-rejection therapy for organ transplant, as treatment for an autoimmune disease.
- More than 3 involved visceral organ sites or more than 6 metastatic lesions.
- Psychiatric disorder or organic brain syndrome that might preclude participation in the protocol.
- Diagnosis of other malignancy in the past 5 years except adequately treated low grade malignancies such as basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma-in-situ of the cervix, or other neoplasm that will not limit life expectancy to less than 5 years.
- Serious cardiac, gastrointestinal, hepatic or pulmonary disease that would make surgical resection high-risk.
- Pregnancy
Sites / Locations
- UC Davis Medical Center
- John Wayne Cancer Institute
- Rush University
- Mayo Clinic Cancer Center
- Buffalo General Hospital
- Wake Forest University
- Ohio State University Medical Center
- Penn State Hershey Cancer Center
- Thomas Jefferson University
- Geisinger Clinic
- Main Line Health System
- Dallas Surgical Group
- UT Southwestern Medical Center at Dallas
- IHC Cancer Services Intermountain Healthcare
- Huntsman Cancer Institute
- Princess Alexandra Hospital
- Tel-Aviv Sourasky Medical Center
- Istituto Nazionale dei Tumori Napoli
- Univesitair Medisch Centrum Groningen
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Best Medical Therapy
Surgery Alone
Surgery + BCG
The best medical therapy group will not initially undergo surgery, but will be treated with the therapy that medical oncologists or surgeons feel is best for the patient. This treatment may include standard or experimental therapies.
The surgery alone group will undergo complete resection (surgical removal) of all known disease, if possible. After surgery, patients will be followed regularly and monitored for disease recurrence.
The Surgery + BCG group will first have a complete resection (surgical removal) of all known disease, if possible. After recovery from surgery, two doses of BCG will be given two weeks apart. Each dose is given as 8 separate injections into the skin (called intradermal injections).