Refusal to accept allogeneic or autologous blood transfusion Failure of, inability to, or refusal to receive standard of care. Refusal to use effective methods of contraception (see inclusion criteria for details). Refusal to practice contraception during chemotherapy Refusal to provide written informed consent Patient refusal to participate in randomization Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons Refusal to sign the informed consent Refusal to sign the informed consent Refusal to sign informed consent Patient refusal Refusal to sign the informed consent Refusal to sign informed consent Refusal or inability to give informed consent to participate in the trial Inability or refusal to practice contraception during therapy (as physiologically relevant) Refusal to sign informed consent Refusal to participate in the long-term follow-up protocol (-) Refusal to participate in the study Patient refusal to participate in randomization Refusal to receive NIPPV Refusal of informed consent Refusal of any cancer treatment(s) Patient refusal to participate (any age), or parental refusal to participate for patients less than years of age Patient refusal to participate in randomization Refusal to provide informed consent Refusal to have an IV placed for injection Refusal to sign the informed consent