Stage IV Resectable Melanoma Clinical Trial
Official title:
A Phase III, Randomized Trial of Surgical Resection With or Without BCG Versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma
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.
This study is designed to examine the impact of surgical resection versus medical therapy as
initial treatment therapy for patients with Stage IV melanoma. Surgical resection is thought
to be efficacious in highly selected patients with solitary metastases, but not in patients
with multiple sites of metastases. Even in those with solitary metastases, there is
considerable debate among major melanoma centers over whether undergoing initial systemic
medical therapy prior to surgical resection should be preferred to initial surgical
resection upon Stage IV diagnosis. According to Dr. Dan Coit, Co-leader of the Melanoma
Disease Management Team at Memorial Sloan Kettering Cancer Institute in New York, a trial of
initial medical therapy is their standard approach on the multidisciplinary melanoma service
even for patients with solitary distant metastases (personal communication, 15 Dec 2009).
Many who favor upfront medical therapy believe that delay before surgical resection may
avoid unnecessary surgery by identifying patients who progress early due to the outgrowth of
occult metastases at multiple sites, which may make the patient unresectable.
This is a Phase III, randomized, international, multicenter study of metastasectomy with or
without BCG versus best medical therapy as initial therapy in Stage IV melanoma. This study
has three arms: surgical resection plus BCG as an immune adjuvant, surgical resection plus
observation, and best medical therapy (BMT). Since no systemic medical therapy has been
demonstrated to be superior to DTIC and multiple new therapies are being evaluated, the
choice as to what constitutes best medical therapy will be determined by the individual
investigator based on the standard of care for systemic medical therapy at that particular
multicenter site. Best systemic medical therapy may include clinical trials of new agents or
standard non-protocol treatments (e.g., DTIC or Temodar according to the standard of care at
the multi-center site).
Patients who progress on the best medical treatment arm may switch to a different medical
therapy or, if appropriate, have surgical therapy; similarly, surgery patients may have
additional surgical resection or receive medical therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment