U.S. ONLY: For all Cohorts, patients who refuse approved therapy for which they are a suitable candidate are not eligible for enrollment on this trial.
Subjects must refuse or be deemed ineligible for cisplatin-based chemotherapy.
Subject must refuse or not be eligible for radiotherapy.
Not a candidate for or refuse chemotherapy
Patients must have had at least one prior therapy to be eligible for either phase I or II, unless they are either not candidates for or refuse cisplatin-based therapy
Patients who refuse to receive blood transfusions
For clinically stage II patients, the patient must have been evaluated by a thoracic surgeon, and deemed medically or technically inoperable, or the patient must refuse surgery
Patients who refuse standard therapy are excluded from the study
Subjects must refuse cisplatin-based combination chemotherapy (and understand the risk and benefits of doing so) or be deemed ineligible for cisplatin-based chemotherapy by meeting at least one of the following criteria:
Women who are pregnant or lactating or refuse to commit to use contraception anytime during the study
Patients of fertile age who refuse contraception for a twelve month period post-transplant
Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapy
Previously untreated RT patients deemed ineligible for, or that refuse, intensive chemotherapy are eligible.
Refuse of use of contraception during trial (both male and female patients)
Patients who may have high burden of disease ie large lesions, who are non-surgical candidates or who refuse surgery
Subjects who refuse blood products.
Patients who are not surgical candidates or refuse surgery
patients who refuse additional radiation therapy.
Patients who refuse to participate
Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy who refuse this therapeutic option and understand the risks and benefits of doing so.
Patients with pTa disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled
Patients who refuse to participate
Subjects who refuse to participate, or demonstrate inability to give informed consent
Subjects who refuse to give and/or sign the informed consent
Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option
Subjects who refuse to participate, or demonstrate inability to give informed consent
Patients who refuse to participate
Patients who refuse to participate
Patients who refuse to participate in the study