CCI-779 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Cancer Institute (NCI); University of Texas; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus

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