pharmacodynamics (pd) and pharmacokinetics (pk) study of ep-100 in advanced solid tumors

Conditions: Solid Tumors; Advanced Solid Tumors

Summary: this study is being done to: * test the safety of ep-100 and see what effect (good and bad) it has on the patient and their cancer; * find the highest dose of ep-100 that can be given without causing bad side effects; * examine how much ep-100 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 ep-100 on the size and activity of cancer in the patient's body.


Eligibility criteria:
inclusion criteria: * subjects with histologically confirmed solid carcinomas * subjects whose tumors over express lhrh receptors in tumor biopsies * tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy * one or more metastatic tumors measurable on ct scan or evaluable disease * karnofsky performance ≥ 70% * life expectancy of at least 3 months * age greater than or equal to 18 years * signed, written informed consent. consent must be provided prior to performing any study-related procedures. * a negative pregnancy test (if female) * acceptable liver function * acceptable renal function * serum creatinine within normal limits, or calculated creatinine clearance greater than or equal to 60 ml/min/1.73 m2 for subjects with creatinine levels above institutional normal. * acceptable hematologic status: * no clinically significant abnormalities * acceptable coagulation status: * for men and women of child-producing potential, the use of 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 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. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * treatment with radiation therapy or investigational therapy within 4 weeks prior to day 1. had received chemotherapy prior to study entry equivalent within 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or mitomycin c). * subjects with active cns metastases are excluded. * subjects with a history of cns metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids. * had major surgery, other than diagnostic surgery, within 4 weeks prior to day 1 * had minor surgery within 2 weeks prior to day 1 * patients who may benefit from hormonal treatment such as breast cancer patients whose tumors are hormone receptor positive (er/pr) and without rapidly progressive visceral disease or patients with prostate cancer who have not had hormonal manipulation therapy. * patients who have potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may acutely progress if ep-100 administration causes a flare reaction. * unwillingness or inability to comply with procedures required in this protocol * known infection with hiv, hepatitis b, or hepatitis c * subjects who are susceptible to histamine release (e.g. patients with mastocytosis, mastocytoma, mast cell leukemia, asthma, hay fever, and other allergic disorders and disorders that increase mast cell numbers). * patients under chronic treatment with corticosteroids. * baseline qtc exceeding 450 msec (using the bazetts formula) and/or patients receiving class 1a or class iii antiarrythmic agents. * serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor * subjects who are currently receiving any other investigational agent * subjects should not be using any lhrh agonists (such as leuprolide \[lupron, eligard\], buserelin \[suprefact, suprecor\], nafarelin \[synarel\], histrelin \[supprelin\], goserelin \[zoladex\], deslorelin \[suprelorin, ovuplant\], triptorelin and others) or antagonists (such as abarelix \[plenaxis\], cetrorelix \[cetrotide\], ganirelix \[antagon\] and others) prior to study treatments. if lhrh agonists are being used, a 4-week washout period is recommended.