CDDO to Treat Solid Tumors and Lymphomas

Inclusion Criteria

• •Patients must have histologically confirmed (by NIH pathology department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which there is not therapy with survival benefit and standard curative or palliative measures do not exist.
• •Patients must have measurable or evaluable disease.
• •Patients must have recovered less than or equal to grade 1 toxicity levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy. They must not have had chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C, 8 weeks for UCN-01). Patients must be at least 1 month since any prior radiation or major surgery. Patients must be greater than or equal to 2 weeks since any prior participation in a Phase Zero study. Patients on bisphosphonates for any cancer or on androgen deprivation therapy for prostate cancer, however, will not need to discontinue this therapy in order to be eligible.
• •Age greater than or equal to 18 years.
• •ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%, see Appendix A).
• •Life expectancy of greater than 3 months.
• •Patients must have normal or adequate organ and marrow function as defined below:
• •Hb greater than or equal to 10 g/dL
• •absolute neutrophil count greater than or equal to 1,500/ L
• •platelets greater than or equal to 100,000/ L
• •total bilirubin less than or equal to 1.5 normal institutional limits
• •AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal
• •creatinine clearance less than 1 x upper limit of normal
• •OR
• •creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
• •The effects of CDDO on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation and for 2 months after discontinuation of the study. Women of child bearing potential must have a negative pregnancy test in order to be eligible. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CDDO, breastfeeding should be discontinued if the mother is treated with CDDO.
• •Ability to understand and the willingness to sign a written informed consent document.