CCI-779 in Treating Patients With Advanced Solid Tumors

The University of Texas Health Science Center at San Antonio15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

temsirolimusDRUG

•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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

San Antonio Cancer Institute

San Antonio, Texas, United States

Data from ClinicalTrials.gov

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