NCT00003712CompletedPhase 1
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
The University of Texas Health Science Center at San Antonio2 sites in 1 country15 target enrollmentStarted: January 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •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
- •Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists
- •Receiving anticonvulsants
- •Measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •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
- •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)
- •Creatinine less than 2 mg/dL
- •Cardiovascular:
- •No unstable angina
- •No myocardial infarction within past 6 months
- •No maintenance therapy for life-threatening arrhythmias
- •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
- •Not specified
- •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
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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