cci-779 in treating patients with advanced solid tumors

Conditions: Brain and Central Nervous System Tumors; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of cci-779 in treating patients who have advanced solid tumors.

objectives: * determine the safety, tolerability, and maximum tolerated dose (mtd) of cci-779 in patients with advanced solid tumors (part i) who are not receiving anticonvulsant therapy. * determine the safety, tolerability, and mtd in patients with recurrent gliomas or brain metastases (part ii) who are receiving anticonvulsant therapy. * determine the preliminary pharmacokinetic profile and antitumor activity of cci-779 in these patients. outline: this is an open-label, dose-escalation study. * part i: patients receive cci-779 iv over 30 minutes on days 1-5, followed by a 9 day rest period. treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. the maximum tolerated dose for part i is defined as the dose level at which 33% of patients experience dose limiting toxicity. * part ii: patients receive the same treatment schedule as part i. three patients with cns tumors are entered at the dose of cci-779 determined to be the mtd in part i. at least 3 patients are entered at each dose level in part ii. projected accrual: approximately 20 patients will be accrued for part i for this study within 8 months, and 12 patients will be accrued for part ii within 7 months.

Eligibility criteria:
disease characteristics: part i: * histologically proven advanced solid tumors that are refractory or for which no curative therapy exists * no cns metastases, peritumoral edema, or symptomatic brain metastases (part i) * measurable or evaluable disease part ii: * histologically proven recurrent gliomas or brain metastases for which no curative therapy exists * receiving anticonvulsants * measurable or evaluable disease patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 3 months hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9 g/dl hepatic: * bilirubin less than 1.5 mg/dl * ast or alt less than 3 times upper limit of normal (uln) (less than 5 times uln if liver metastases) renal: * creatinine less than 2 mg/dl cardiovascular: * no unstable angina * no myocardial infarction within past 6 months * no maintenance therapy for life-threatening arrhythmias other: * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no active infection or other serious concurrent illness * triglycerides no greater than 300 mg/dl * cholesterol no greater than 350 mg/dl * no known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin) prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) * no other concurrent chemotherapy endocrine therapy: * concurrent corticosteroids used to reduce edema in patients with primary or metastatic cns tumors allowed * no concurrent hormonal therapy radiotherapy: * at least 3 weeks since prior radiotherapy * no concurrent radiotherapy surgery: * not specified other: * at least 1 month since prior investigational agents * at least 3 weeks since prior immunosuppressive therapy * no concurrent anticonvulsant therapy (part i) * no concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide) * no known agents that inhibit or induce cytochrome p450

Keywords: recurrent adult brain tumor unspecified adult solid tumor, protocol specific tumors metastatic to brain