Ability to sign written informed consent Ability to give written informed consent Ability to give written informed consent Ability to understand a written informed consent Ability to give written informed consent Ability of participant to sign a written informed consent Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy Patient must have the ability to give written informed consent Ability to sign written informed consent Ability to understand and complete written informed consent Ability to give written informed consent. Have the ability to give written informed consent Ability to sign written informed consent Ability to understand informed consent and signing of written informed consent prior to initiation of protocol therapy Have the ability to understand and to give written informed consent as assessed by the participants primary care physician or medical oncologist