9. At the time of enrollment, patients must be greater than 4 weeks since major surgery, radiotherapy, chemotherapy (greater than or equal to 6 weeks if they were treated with a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab), immunotherapy, or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to less than or equal to Grade 1, exclusive of alopecia. Concurrent cancer therapy is not permitted. (In patients who received long-acting agents, a treatment-free interval of 2 half-lives should be considered.)