Stage IV Surgery Versus Best Medical Therapy

Stopped early · Phase 3

Conditions studied: Stage IV Resectable Melanoma

In brief

This study will establish the role of surgical versus nonsurgical approaches in patients whose melanoma has spread to distant sites. Results will help clinicians develop a standardized initial approach that prolongs survival and optimizes quality of life. Results also will indicate whether Bacillus Calmette-Guerin (BCG) postoperative immunotherapy significantly improves the outcome of patients treated with surgery.

Key facts

Study ID

NCT01013623

Run by

Saint John's Cancer Institute

People needed

12

Starts

2009-11-01

Expected to finish

2012-09-01

Last updated by the study team

2012-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Rush University — Chicago, Illinois, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Buffalo General Hospital — Buffalo, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Penn State Hershey Cancer Center — Hershey, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Geisinger Clinic — Wilkes-Barre, Pennsylvania, United States
• Main Line Health System — Wynnewood, Pennsylvania, United States
• Dallas Surgical Group — Dallas, Texas, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• IHC Cancer Services Intermountain Healthcare — Murray, Utah, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Princess Alexandra Hospital — Brisbane, Queensland, Australia
• Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel
• Istituto Nazionale dei Tumori Napoli — Naples, Italy
• Univesitair Medisch Centrum Groningen — Groningen, Netherlands

Full record on ClinicalTrials.gov

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