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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Advanced Solid Tumors  CCI-779 in Treating Patients With Advanced Solid Tumors
CCI-779 in Treating Patients With Advanced Solid Tumors
For Condition: brain metastases,recurrent adult brain tumor,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): San Antonio Cancer Institute ,
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain metastases (part II) who are receiving anticonvulsant therapy. III. Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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) Part II: - Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists - Receiving anticonvulsants Parts I and II: Measurable or evaluable disease --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 --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/mm3 - Platelet count at least 100,000/mm3 - 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricRowinsky, Study Chair, San Antonio Cancer Institute
San Antonio Cancer Institute
San Antonio, Texas, 78229-3264
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000066820; UTHSC-9785011303,NCI-V98-1506,SACI-IDD-98-02,W-AR-3066K1-100-US
Study Start Date: July 1998
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003712
Other Brain Metastases Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
3. KRN5500 in Treating Patients With Solid Tumors
4. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
5. BMS-214662 in Treating Patients With Solid Tumors
Related Studies:
Other brain metastases Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
CCI-779 in Treating Patients With Advanced Solid Tumors
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