lower dose decitabine based therapy in patients with refractory and/or chemotherapy resistant solid tumors or b cell lymphomas

Conditions: Solid Tumors; B Cell Lymphoma

Summary: determine alone or in combination with chemotherapy or autologous cytokine induced killer cells are effective and safe in the treatment of patients with relapsed and/or refractory solid tumors or b cell lymphomas.

the purpose of this study is to determine whether lower dose decitabine based therapy is safe and can effectively control tumor progression.

Eligibility criteria:
inclusion criteria: * solid tumor * histologically confirmed advanced solid tumor * 1 to 3 prior treatment regimens * at least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computerized tomography (ct) scanning technique or ≥ 1 cm in the largest dimension by spiral ct scanning (per recist criteria); or if, in the principal investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the medical monitor * b cell lymphoma * histologically or cytologically confirmed b cell lymphoma. * patients must have had an initial diagnosis of b cell nhl (including follicular, small lymphocytic, lymphoplasmacytoid, and marginal zone lymphoma), indolent disease that transformed to a more aggressive subtype, as previously described or patients may have mantle cell lymphoma. * patients are required to have received prior chemotherapy (alone or combined with rituximab or other treatment) and are considered refractory to (defined as no response, or progression within 6 months of completing therapy) or intolerant of continued rituximab or other treatment. * patients may have received up to a maximum of four prior unique chemotherapy regimens, including if not contra-indicated autologous stem-cell transplantation (asct). * for patients to enroll in the expanded dose group for lymphoma, patients must have measurable disease exclusion criteria: * disease related * chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy * radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose * subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (cns) disease for at least 4 weeks prior to first dose * for lymphoma patients; patients with prior stem cell transplant therapy (autologous sct within the prior 8 weeks; allogeneic sct within the prior 16 weeks). patients with prior allogeneic sct should not have evidence of moderate-to-severe gvhd. * participation in an investigational therapeutic study within 3 weeks prior to first dose * prior treatment with decitabine concurrent conditions * major surgery within 3 weeks prior to first dose * congestive heart failure (new york heart association class iii to iv), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 3 months prior to first dose * acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose * known or suspected hiv infection or subjects who are hiv seropositive * active hepatitis a, b, or c infection * significant neuropathy (grade 3, grade 4, or grade 2 with pain) at the time of the first dose ethical / other * female subjects who are pregnant or lactating * any clinically significant psychiatric or medical condition that in the opinion of the investigator could interfere with protocol adherence or a subject's ability to give informed consent

Keywords: advanced solid tumors b cell lymphoma