Stage IV Resectable Melanoma Clinical Trial
— STG4SURGOfficial title:
A Phase III, Randomized Trial of Surgical Resection With or Without BCG Versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma
Verified date | September 2012 |
Source | John Wayne Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: 1. WBC >3,000/mm3 2. Lymphocytes >800/mm3 3. Platelets >100,000/mm3 4. Creatinine <2.0 mg/dL 5. Bilirubin <2.0 mg/dL 6. Alkaline phosphatase < 2X upper limit of normal (ULN) 7. SGOT < 2X ULN 8. SGPT < 2X ULN 9. 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Israel | Tel-Aviv Sourasky Medical Center | Tel-Aviv | |
Italy | Istituto Nazionale dei Tumori Napoli | Naples | |
Netherlands | Univesitair Medisch Centrum Groningen | Groningen | |
United States | Buffalo General Hospital | Buffalo | New York |
United States | Rush University | Chicago | Illinois |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Dallas Surgical Group | Dallas | Texas |
United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Penn State Hershey Cancer Center | Hershey | Pennsylvania |
United States | IHC Cancer Services Intermountain Healthcare | Murray | Utah |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | UC Davis Medical Center | Sacramento | California |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | John Wayne Cancer Institute | Santa Monica | California |
United States | Geisinger Clinic | Wilkes-Barre | Pennsylvania |
United States | Wake Forest University | Winston-Salem | North Carolina |
United States | Main Line Health System | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
John Wayne Cancer Institute | Melanoma Research Alliance |
United States, Australia, Israel, Italy, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Defined as time from randomization to death from any cause | 3 interim analyses will be conducted when 75, 148, and 217 events (deaths) have occurred. The final analysis will be conducted when all 284 expected events have occurred. | No |
Secondary | Time to progression of initial metastatic sites (progression-free survival) | For this study, PFS is defined as the time from randomization to disease recurrence at initial metastatic site in patients rendered disease-free by surgery, or time from randomization to RECIST-defined progression of target lesions in patients receiving best medical therapy or those having residual disease following surgery. | 3 interim analyses will be conducted when 75, 148, and 217 primary events have occurred. The final analysis will be conducted when all 284 expected events have occurred. | No |
Secondary | Melanoma-specific survival | Defined as time from randomization to death due to melanoma. Death due to causes other than melanoma are not considered events for this analysis. | 3 interim analyses will be conducted when 75, 148, and 217 recurrences/progressions have occurred. The final analysis will be conducted when all 284 expected events have occurred. | No |
Secondary | Time to development of new metastatic sites. | This endpoint is defined as the time from randomization to disease recurrence at new metastatic sites in patients rendered disease-free by surgery, or time from randomization to the development of new metastatic sites of disease in patients in the best medical therapy group. Progression of existing lesions in the best medical therapy arm will not be considered an event for this endpoint. | 3 interim analyses will be conducted when 75, 148, and 217 primary events have occurred. The final analysis will be conducted when all 284 expected events have occurred. | No |