study of go-203-2c given intravenously in patients with advanced solid tumors including lymphomas

Conditions: Solid Tumors

Summary: this clinical trial is about testing go-203-2c, which is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called muc1 (which is over-expressed in many cancers). by binding to muc1, go-203-2c eventually causes tumor cell death in laboratory studies. this study is being done to: * test the safety of go-203-2c and see what effects (good and bad) it has on you and your cancer * find the highest dose of go-203-2c that can be given without causing bad side effects * examine how much go-203-2c is in the blood at certain times after it is given and how quickly the body gets rid of it * observe whether there is any effect of go-203-2c on the size and activity of cancer in your body


Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumors or lymphomas * tumor progression observed after receiving standard/approved systemic chemotherapy and/or immunotherapy including monoclonal antibodies, or when there is no approved or effective therapy * one or more measureable tumors by radiological evaluation * karnofsky performance ≥ 70% * life expectancy of ≥ 3 months * age ≥ 18 years * signed, written irb-approved informed consent * negative pregnancy test (if female) * adequate liver function: * bilirubin less than or equal to 1.5 x upper limit of normal (uln) * ast (sgot), alt (sgpt) and alkaline phosphatase less than or equal to 2.5 x uln (if liver metastases are present, then less than or equal to 5 x uln is allowed) * adequate renal function: * serum creatinine within normal limits, or calculated creatinine clearance ≥ 60 ml/min/1.73 m2 for patients with serum creatinine above institutional uln. * corrected serum calcium ≥ lower limit of the institutional normal range (lln) * serum phosphorus level ≥ lln * adequate hematologic function: * absolute neutrophil count ≥ 1500 cells/mm3 * platelet count ≥ 100,000 (cells/mm3) * hemoglobin ≥ 9 g/dl * urinalysis: * no clinically significant abnormalities * adequate coagulation function: * pt ≤ 1.25 x uln * ptt ≤ 1.25 x uln * for men and women of child-producing potential, agreement to use effective contraceptive methods during the study exclusion criteria: * new york heart association class iii or iv, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ecg * active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy * pregnant or nursing women. note: women of childbearing 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. should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. * major surgery within 4 weeks prior to day 1, or not fully recovered by day 1 * minor surgery within 2 weeks prior to day 1, or not fully recovered by day 1 * treatment with radiation therapy within 4 weeks prior to day 1. * received systemic chemotherapy or monoclonal antibody or other immunotherapy within 4 weeks prior to day 1 (exceptions: 6 weeks for nitrosourea, mitomycin c, or any agent with a known treatment effect \> 4 weeks' duration), or not fully recovered from any side effects from previous therapy by day 1 * history of allergic reactions attributed to excipients or chemical products used in the final go-203-2c drug formulation * known infection with hiv, hepatitis b, or hepatitis c. * subjects with risk factors for gastrointestinal perforation or pulmonary hemorrhage (e.g. unresected luminal intestinal cancers; abdominal carcinomatosis within 3 months before the first dose of study drug, abdominal fistula, acute diverticulitis, peptic ulcer disease, irritable bowel syndrome, crohn's disease, pulmonary hemorrhage, hemoptysis, or tuberculosis) * currently receiving or having received treatment with any other investigational agent within 4 weeks prior to day 1, or not fully recovered from toxicities of prior treatment by day 1 * serious and/or poorly controlled non-malignant disease (including but not limited to, ongoing or active infection, hydronephrosis, hypertension, diabetes, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. patients with such conditions should be discussed with the medical monitor prior to enrollment. all medical conditions must be nci ctcae grade 1 or lower at baseline. * unwillingness or inability to comply with requirements of this protocol

Keywords: cancer