Brain and Central Nervous System Tumors, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
recurrent adult brain tumor, unspecified adult solid tumor, protocol specific, tumors metastatic to brain
Brief 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.
Detailed description
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.
Interventions
DRUGtemsirolimus
•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.
Sponsors
National Cancer Institute (NCI)
University of Texas
Wyeth is now a wholly owned subsidiary of Pfizer
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed