A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors
temsirolimus
Brain Diseases+9
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: January 1, 2001
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
San Antonio Cancer Institute
San Antonio, United States