phase i study of cs-7017 and bexarotene

Conditions: Solid Tumors; Lymphoma; Multiple Myeloma

Summary: this study is for patients with advanced solid tumors. the purpose of this study is to test the safety and effectiveness of a new combination of drugs, cs-7017 and bexarotene in patients with advanced cancer. cs-7017 and bexarotene both have many effects on cancer cells, including stopping cancer cells from growing and dividing, and causing the cancer cells to die. cs-7017 and bexarotene work on cancer cells in a similar manner and both drugs together may have an even greater effect against cancer cells, hopefully, increasing the killing of cancer cells. cs-7017 is an investigational or experimental anti-cancer agent that has not yet been approved by the food and drug administration (fda) for use in any type of cancer. bexarotene is an anti-cancer agent that has been approved by the fda for patients with a specific type of cancer, cutaneous t-cell lymphoma. this study will help find out what effects the combination of drugs, cs-7017 and bexarotene, has on cancer. this research is being done because it is not known if cs-7017 is safe to be given with bexarotene.


Eligibility criteria:
inclusion criteria: * histologically proven advanced malignancy with measurable disease except for acute leukemias * progression on, or intolerance of, or ineligibility for all standard therapies * biopsy accessible tumor deposits * lvef \>/= institutional normal * no evidence of clinically significant fluid retention * ecog performance status 0-2 * subjects with no brain metastases or a history of previously treated brain metastases who have been treated with surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline mri that shows no evidence of intracranial disease and have not had treatment with steroids within one week of study enrollment. * adequate hepatic, bone marrow, and renal function * partial thromboplastin time must be \</= 1.5 x upper limit of normal range and inr \< 1.5. subjects on anticoagulant will be permitted to enroll as long as the inr is in the acceptable therapeutic range * life expectancy \> 12 weeks * women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent. exclusion criteria: * prior cs-7017 treatment * treatment with thiazolidinediones (tzds) within 4 weeks prior to start of study treatment * current need for concomitant use of other tzds during the study * grade 2 or greater fasting hypertriglyceridemia * concurrent use of insulin * concurrent use of known cyp 3a4 inhibiting or activating medications * cns metastases which do not meet the criteria outlines in inclusion criteria * active severe infection or known chronic infection with hiv or hepatitis b virus * cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke or congestive heart failure within the last 6 months * life-threatening visceral disease or other severe concurrent disease * women who are pregnant or breastfeeding * anticipated survival under 3 months * clinically significant and uncontrolled major medical condition(s)

Keywords: advanced cancer