CCI-779 in Treating Patients With Advanced Solid Tumors
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About
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.
Full 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.
Enrollment
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Inclusion and exclusion 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
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Data sourced from clinicaltrials.gov
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