A Prospective Phase II Study of Radiation Therapy and Concurrent Cisplatin Chemotherapy in the Treatment of Locally Advanced or Metastatic Malignant Melanoma
This is a phase II, prospective trial designed to determine the response rate achieved with
cisplatin delivered concurrent with radiation therapy in locally advanced or metastatic
Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in
table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20
treatments). Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2
doses (days 1 and 22) during radiation.
Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be
performed following chemoradiation if deemed appropriate by the treating physicians
(surgical resection may be planned following pre-operative chemoradiation or may be
performed for salvage due to inadequate response to chemoradiation or for relapse following
chemoradiation). Surgical resection will not be performed until at least 4 weeks following
chemoradiation (unless deemed emergent by the treating physicians).
If the patient's tumor has inadequate response to chemoradiation then salvage therapies can
be used as deemed appropriate by the treating physicians. In order to allow adequate
response to radiation therapy, salvage therapies will not be utilized until at least 4 weeks
following chemoradiation unless deemed emergent by the treating physicians.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate of Melanoma Lesions
Response rate of melanoma lesions was measured after treated with the trial agent.
Dennis Shrieve, MD
Huntsman Cancer Institute
United States: Institutional Review Board
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|LDS Hospital||Salt Lake City, Utah 84143|