Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infection Patient must not have an intercurrent illness likely to interfere with protocol therapy Other severe acute or chronic medical or psychiatric condition or laboratory abnormality Patients with known serious concurrent infection or medical illness, including psychiatric disorders A medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Patients with an active infection or serious intercurrent medical illness ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled Has a serious illness or medical condition(s) Any significant acute or chronic medical illness Other acute or chronic medical or psychiatric condition Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol Patients with an active infection or serious intercurrent medical illness are ineligible Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the patient from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study. Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent. Any serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient nonevaluable, put the patient's safety at risk, or prevent the patient from following the study requirements. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Patients with any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol are not eligible Any other significant medical illness, abnormality, or condition Serious illness or medical condition. Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up Any serious medical condition, laboratory abnormality, or psychiatric illness that would – in the opinion of the investigator – prevent the subject from signing the informed consent form Serious psychiatric or medical conditions that could interfere with treatment Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study. Subject with a serious concurrent infection or medical illness that would jeopardize the ability of the subject to receive study treatment with reasonable safety. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent study participation Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent study participation Patient with serious medical of psychiatric illness likely to interfere with participation on this clinical study Individuals with major medical or psychiatric illness which would prevent the completion of study treatment and/or interfere with follow up are excluded from this study Participant has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the treatment according to this protocol or complete the study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent. Any serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient nonevaluable, put the patient's safety at risk, or prevent the patient from following the study requirements. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Psychiatric disorders that would interfere with consent Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Uncontrolled serious medical or psychiatric illness Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the consent form Patients with any serious or medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Patients with an active infection or serious intercurrent medical illness are ineligible Known diagnosis of human immunodeficiency virus, active chronic hepatitis B, or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g., infectious) illness Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study). Patients should have NO significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition Major medical, addictive or psychiatric illness which in the investigator’s opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study) Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent. Patient must not have serious medical or psychiatric illness likely to interfere with participation in this clinical study in the opinion of the investigator. Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator’s opinion, potentially interfere with participation in this study Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator Patients with any concurrent uncontrolled clinically significant medical condition, including infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol. Major medical illnesses or psychiatric impairments, which in the investigator’s opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study procedures Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment Active, uncontrolled serious infection or medical or psychiatric illness, that in the investigator’s opinion is likely to interfere with participation in this clinical trial Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study procedures Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which, in the opinion of the investigator, would compromise the subject’s safety or interfere with data interpretation Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient’s ability to carry out the treatment program Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment Any other sound medical, psychiatric, and/or social reasons as determined by the investigator Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Another significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocol Subject who, in the opinion of the Investigator, has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits Uncontrolled intercurrent illness including medical, psychiatric, cognitive or other conditions, psychiatric illness/social situations that would compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study or, in the judgment of the principal investigator, would make the patient inappropriate for study participation Serious psychiatric or medical conditions that could interfere with treatment History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the investigator’s judgment, make the patient inappropriate for this study Serious inter-current medical illness which would interfere with the ability of the patient to carry out the treatment program Patients must not have active infection or serious intercurrent medical illness. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent Mental incapacitation or psychiatric illness that would preclude study participation Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process A serious illness or medical condition Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study Psychiatric illness, which would prevent the patient from giving informed consent Any other clinically significant medical or psychiatric disease or condition or social situation that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent Active, uncontrolled, serious infection, or medical, or psychiatric illness likely to interfere with participation in this clinic trial Significant medical or psychiatric disorder that would interfere with consent, study participation, or follow-up Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Serious psychiatric or medical conditions that could interfere with treatment Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator’s judgment, make the patient inappropriate for this study Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient’s ability to carry out the treatment program Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical illness, other than that treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consent Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent Serious psychiatric or medical conditions that could interfere with treatment or protocol-related procedures. Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness, which could place him/her at unacceptable risk Any serious medical or psychiatric illness that could, in the site investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Serious medical or psychiatric illness/condition likely in the judgment of the Investigator to interfere with compliance to protocol treatment/research Any serious medical illness, other than treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consent Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator’s opinion, potentially interfere with participation in this study Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Patients should not have a history of significant psychiatric illness Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol No serious medical illness that would potentially increase patients’ risk for toxicity Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness, including drug or alcohol abuse that could, in the investigator's opinion, potentially jeopardize the safety of the participant or interfere with the objectives of the study. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Subjects with any serious medical or psychiatric disorder that would interfere with subject safety or informed consent Serious medical illness that would potentially increase patients’ risk for toxicity Serious psychiatric or medical conditions that could interfere with treatment Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study Serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical illness that would potentially increase patients’ risk for toxicity Significant underlying medical or psychiatric illness The patient has a psychiatric illness or developmental delay that would interfere with understanding of the study and provision of informed consent Uncontrolled intercurrent illness including, but not limited to, active infection, poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study Have additional uncontrolled serious medical or psychiatric illness. Other serious medical illness other than that treated by this study which would limit survival to <2 years or psychiatric conditions which would prevent informed consent or compliance with treatment. Patients must not have a serious medical or psychiatric illness likely to interfere with study participation RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation Patients with serious unstable medical illness Any major medical psychiatric or neurologic illness, which in the investigators' opinions would interfere with either completion of therapy or with full and complete understanding of the risks and potential complications of the therapy Any serious psychological condition or psychiatric illness that would prevent the subject from signing the informed consent document, in the investigator opinion Serious medical illness that would potentially increase patients’ risk for toxicity Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment Serious psychiatric or medical conditions that could interfere with treatment Serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient’s ability to tolerate this treatment Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment Patients has an active infection or serious intercurrent medical illness Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Patients with serious unstable medical illness Significant underlying medical or psychiatric illness. All patients must be consented prior to chemotherapy; the patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Patients should not have a history of significant psychiatric illness Major medical or psychiatric illness which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow up Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow-up Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Significant underlying medical or psychiatric illness Significant underlying medical or psychiatric illness Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow-up Major psychiatric illness, which would prevent completion of treatment or interfere with follow up Psychiatric illness that may affect the patient's compliance with the treatment. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study procedures Serious psychiatric or medical conditions that could interfere with treatment Patients who have any serious condition, laboratory abnormality, or psychiatric illness that would prevent them from singing the informed consent form are NOT eligible for participation Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol. Other serious illness or medical condition(s) (see protocol) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g., infectious) illness Have psychiatric or other medical illness, or any other condition that in the opinion of the investigator prevents compliance with the study procedures or ability to provide valid informed consent. Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment Evidence of any other serious medical condition (such as psychiatric illness, infectious diseases, physical or laboratory findings) that may interfere with the planned treatment, affect compliance or place the patient at high risk from treatment-related complications or potentially interfere with the completion of the treatment as per the protocol History of a significant medical illness deemed by the principal investigator (PI) as unsuitable for the trial; for example: i. symptomatic congestive heart failure; ii. psychiatric illness/social situation that may make study dangerous; iii. unstable angina pectoris Serious medical illness that would potentially increase patients’ risk for toxicity No serious medical or psychiatric illness which prevents informed consent or intensive treatment is allowed Life-threatening illness unrelated to cancer or any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with participation in this study. Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Other serious illness or medical conditions Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent Must have no medical or psychiatric illnesses that would interfere with treatment or follow-up Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness Patients who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the study Any other clinically significant medical or psychiatric disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent Any significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent subjects from participating in the study, including the inability to swallow capsules Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness Non-compliance; a patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious inter-current medical illness which would interfere with the ability of the patient to carry out the treatment program Patients with serious unstable medical illness No serious concurrent medical illness or active infection which would jeopardize the ability of the patient to receive the treatment outlined in this protocol Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient’s ability to tolerate this treatment Serious intercurrent medical or psychiatric illness including serious active infection Medical Conditions The participant has a serious illness or medical condition including: Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any other significant medical illness, abnormality, or condition. Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Medical or psychiatric illness or social situations that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the Investigator's judgment, make the patient inappropriate for this study Serious intercurrent medical or psychiatric illness, including serious active infection Serious intercurrent medical or psychiatric illness that will prevent participation or compliance with study procedures, including serious active infection Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent. Have serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Any significant medical condition, laboratory abnormality, or psychiatric illness Major medical or psychiatric illnesses which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow up Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent Patients must not have any serious medical condition or any other unstable medical co-morbidity, or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Have additional uncontrolled serious medical or psychiatric illness that in the point of view of the investigator can render the patient unable to receive therapy or make it unsafe to receive therapy. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Serious medical or psychiatric illness likely to interfere with participation in this clinical study Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures or could limit participant expected survival to less than 6 months. Significant psychiatric illness Another significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocol If the patient has co-morbid medical illness, life expectancy attributed to the comorbid illness must be greater than 6 months Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent Significant or acute medical illness Major medical or psychiatric illness which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow up Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients must not have a serious medical or psychiatric illness likely to interfere with study participation Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form, which places the subject at unacceptable risk if he/she were to participate in the study or which confounds the ability to interpret data from the study Serious intercurrent medical or psychiatric illness, including serious active infection Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Evidence of significant medical illness, abnormal laboratory finding or psychiatric illness/social situations that would, in the investigator’s judgment, makes the patient inappropriate for this study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with a serious unstable medical illness or another active cancer Has other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study start Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient’s ability to carry out the treatment program Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study. Serious psychiatric illness or addiction likely to interfere with participation in this clinical study Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form Serious psychiatric or medical conditions that could interfere with treatment Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Subjects who have a history of significant psychiatric illness Serious concurrent illness, altered medical status or any uncontrolled medical condition Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Have no active cardiac, neurologic, or psychiatric illness, and Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Serious psychiatric or medical conditions that could interfere with treatment Serious psychiatric illness (e.g., depression, psychosis) or medical conditions that could interfere with treatment Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent No significant co-morbid medical or psychiatric illness that would significantly compromise the patient’s clinical care and chances of survival Serious psychiatric or medical conditions that could interfere with treatment Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Other serious concurrent illness or medical condition. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation The patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study. Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up. Hospitalized for psychiatric illness within the past two years Patient has a serious medical or psychiatric illness which prevents informed consent or adherence with treatment Other acute or chronic medical or psychiatric conditions. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures Serious medical illness that would potentially increase patients’ risk for toxicity Any clinically significant medical or psychiatric condition that would interfere with protocol treatment Any clinically significant medical or psychiatric condition that would interfere with protocol treatment Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol Serious medical illness that would potentially increase patients’ risk for toxicity Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator. Serious medical illness that would potentially increase patients’ risk for toxicity Patients must NOT have active or uncontrolled infection or serious medical or psychiatric illness Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study Significant concurrent medical or psychiatric illness which, in the opinion of the principal investigator would interfere with trial participation Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with participation or completion of treatment according to this protocol Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent Any serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent form Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol Serious medical or psychiatric illness likely to interfere with participation in this clinical study Excluded medical conditions: Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications Any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment Serious intercurrent medical or psychiatric illness, including serious active infection Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study. Cognitive impairment, history of medical or psychiatric disease, other uncontrolled intercurrent illness, active substance abuse, or social circumstances, which in the view of the principal investigator (PI), would preclude safe treatment or the ability to give informed consent Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form No other significant medical or psychiatric problems that would preclude study participation or interfere with capacity to give informed consent. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study. Patients must not have active infection or serious intercurrent medical illness Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Severe concomitant medical or psychiatric illness Serious medical or psychiatric illness likely to interfere with participation in this clinical study Certain serious illness or medical condition(s) Significant active concurrent medical illness or infection precluding protocol treatment or survival For Part D, have a serious illness or medical condition(s), including but not limited to the following: Patient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol Major medical or psychiatric illness, which in the investigator's opinion would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. No serious medical or psychiatric illness likely to interfere with participation in this clinical study Known serious illness or medical condition Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety Participant with a serious medical or psychiatric illness likely to interfere with participation in the study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Have other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study start Patients with serious psychiatric or medical conditions that could interfere with treatment Patients with serious unstable medical illness Other serious concurrent illness or medical condition. No serious medical or psychiatric illness which prevents informed consent or intensive treatment Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol; in particular, a history of a serous psychiatric illness that might be exacerbated by IFN-alpha-2b; a history of significant or unstable cardiovascular, hepatic or gastrointestinal disease; a history of autoimmune disease of any kind Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Serious psychiatric or medical conditions that could interfere with treatment Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Serious medical illness that would potentially increase patients’ risk for toxicity Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Concomitant medical or psychiatric illness that is likely to interfere with a reasonably safe execution of the treatment plan Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consent Serious intercurrent medical or psychiatric illness Serious cardiac illness or medical conditions Patients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up Any serious illness or medical condition that could affect participation on trial Serious medical or psychiatric illness likely to interfere with participation in this clinical study Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. History of a significant medical illness deemed by the PI or local investigators as unsuitable for the trial. For example: i. Symptomatic congestive heart failure ii. Psychiatric Illness/social situation that may make study dangerous iii. Unstable angina pectoris Patients with serious unstable medical illness Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Serious cardiac illness or medical condition including but not confined to: Patients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocol Concurrent serious medical illness that could potentially interfere with protocol compliance (such medical illness will not include hepatitis or cirrhosis, as the degree of liver impairment caused by these diseases are covered by other exclusion criteria). Patients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocol Serious psychiatric or medical conditions that could interfere with treatment Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy. Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Any life-threatening or serious medical or psychiatric illness unrelated to cancer that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form Other serious concurrent illness or medical condition. Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent. Any serious medical or psychiatric illness Comorbid systemic illness or psychiatric illness that could interfere with study completion Any serious medical or psychiatric illness Serious medical or psychiatric illness likely to interfere with participation in this clinical study Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Serious psychiatric or medical conditions that could interfere with treatment Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation Any serious medical condition, lab abnormality or psychiatric illness Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study per the judgment of the treating physician Serious psychiatric or medical conditions that could interfere with treatment Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Have additional uncontrolled serious medical or psychiatric illness. Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator’s decision) A medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol Has serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form Patients with a serious unstable medical illness or another active cancer Severity of any medical illness that, in the Investigator's judgement, justifies hospitalization of the subject for treatment and supportive care Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Severe concomitant medical or psychiatric illness Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent Patients who have active or uncontrolled infection or serious medical or psychiatric illness preventing informed consent or on intensive treatment Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Serious psychiatric or medical conditions that could interfere with treatment Active, uncontrolled, serious infection or medical or psychiatric illness likely to interfere with participation in this clinic trial Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up Significant psychiatric disturbance verified by medical record sufficient to preclude completion of the assessment measures, interview or informed consent (i.e. acute psychiatric symptoms which require individual treatment) Diagnosis of major mental illness on the medical record (verified by the recruiter) Patients with any medical illness or concurrent psychiatric illness which, in the investigators’ opinion, cannot be adequately controlled with appropriate therapy Significant acute or chronic medical illness. Any serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent form Patients with any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. History of hospitalization for psychiatric illness Self-report of hospitalization for psychiatric illness within the last two years Unstable self-reported medical or psychiatric illness (Axis I – current or within the last 5 years) that would make it unsafe or impossible to adhere to the study protocol Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits Any medical condition that may interfere with ability to receive protocol treatment Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol Any serious medical condition, laboratory abnormality or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study Any significant medical condition, laboratory abnormality, or psychiatric illness that, as determined by the treating Investigator, would prevent the subject from participating in the study or providing written informed consent No serious medical or psychiatric illnesses that would prevent informed consent; patients with post-obstructive pneumonia are eligible; patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment are ineligible Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol Psychiatric illness that would prevent the patient from giving informed consent No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up Any medical condition that may interfere with ability to receive protocol treatment Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator or collaborator Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate therapy, per the discretion of the treating investigator Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator Patient has significant medical or psychiatric conditions that would make the patient a poor protocol candidate Significant medical or psychiatric conditions that would make the patient a poor protocol candidate Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator´s judgment. Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol Serious intercurrent medical illness Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up History of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s) Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent Severe psychiatric illness Patients who because of general medical or psychiatric condition or physiologic status cannot give valid informed consent Severe psychiatric illness No serious medical or psychiatric illnesses that would prevent informed consent Inability to perform informed consent due to any medical or psychiatric condition No uncontrolled serious medical or psychiatric illness Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. Has a serious illness or medical condition(s) Subject has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol Have been hospitalized for treatment of a major psychiatric illness within the last five years Poorly controlled hypertension, DM or other serious medical/psychiatric illness Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer. Serious psychiatric illness, alcoholism, or drug addiction Has any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.