A Phase-I Dose-Escalation Trial of Boron Neutron Capture Therapy for Subjects with Metastatic Subcutaneous Melanoma of the Extremities
Three subjects have completed the New England Medical Center—Massachusetts Institute of Technology phase-I boron neutron capture therapy dose-escalation melanoma protocol. The irradiations were done with a single 15 cm diameter field of epithermal neutrons from the MIT Research Reactor employing four daily fractions. There was no observed acute boron compound toxicity or thus far, with a follow-up of 5–7 months, no radiation induced normal tissue reactions or any other untoward events related to the high oral doses of the boron compound or to the neutron irradiations. In all three cases, even at the first dose level of 1,000 RBE-cGy to normal tissue (RBEs used were: 4 for neutrons and the B-10 reaction products, and 0.5 for gamma rays), there was clear partial response of the melanoma nodules within the irradiation field in at least two of the three subjects. The next step in the protocol is to increase the dose level by 25% for an additional three subjects and to continue until moderate normal tissue radiation toxicity is observed. At that point the phase-I protocol will evolve into a phase-II protocol.
KeywordsNeutron Irradiation Boron Neutron Capture Therapy Epithermal Neutron Brookhaven National Laboratory England Medical
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