monoclonal antibody therapy in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase i trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced solid tumors.

objectives: * determine the maximum tolerated dose and recommended phase ii dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors. * determine the toxic effects of this drug in these patients. * determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * determine the potential anti-tumor activity of this drug in these patients. outline: this is a dose-escalation study. patients receive monoclonal antibody anti-anb3 integrin iv over 30 minutes weekly. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, additional patients are treated as above at that dose level. projected accrual: a total of 27-33 patients will be accrued for this study within 9-11 months.

Eligibility criteria:
inclusion criteria disease characteristics: * histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists * measurable or evaluable disease * must have clinical or radiological evidence of disease * disease must be accessible to biopsy and imaging studies * no known brain metastases patient characteristics: age * 18 and over performance status * eastern cooperative oncology group (ecog) 0-2 life expectancy * at least 3 months hematopoietic * absolute neutrophil count at least 2,000/mm\^3 * platelet count at least 100,000/mm\^3 * no prior bleeding disorder hepatic * bilirubin no greater than 1.2 mg/dl * alanine aminotransferase test (alt) and aspartate aminotransferase (ast) no greater than 2.5 times upper limit of normal (uln) * prothrombin time (pt)/ partial thromboplastin time (ptt) no greater than uln renal * creatinine less than 1.5 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study * willing to be premedicated for delayed contrast-enhanced mri * no prior claustrophobia * no dementia or altered mental status that would preclude informed consent * no other uncontrolled concurrent illness * no ongoing or active infection * no psychiatric illness or social situations that would preclude study compliance * no immunodeficiency * hiv negative * must be willing to receive blood products * no thyroid disease * thyroxine and thyroid-stimulating hormone no greater than uln prior concurrent therapy: biologic therapy * at least 4 weeks since prior immunotherapy exclusion criteria chemotherapy * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * prior taxanes allowed * no concurrent chemotherapy endocrine therapy * no concurrent hormonal therapy except: * concurrent hormonal replacement therapy * concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer radiotherapy * at least 4 weeks since prior radiotherapy and recovered * no prior radiotherapy to more than 25% of the bone marrow * no concurrent radiotherapy surgery * more than 4 weeks since prior surgery other * no other concurrent investigational or commercial agents or therapies for the malignancy * no other concurrent antitumor therapy