Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer. Determine the safety and tolerability of this regimen in these patients. Determine, preliminarily, any antitumor activity of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive interferon alfa (IFN-A) subcutaneously 3 times a week. Beginning on week 2, patients also receive CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at that dose level. Patients are followed at 30 days. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.

Official Title
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A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Intravenous CCI-779 Given in Combination With Escalating Doses of Interferon-Alpha to Patients With Advanced Renal Cancer

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: temsirolimus


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic renal cell cancer Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease Measurable or evaluable disease No concurrent CNS metastases Prior CNS metastases allowed if no residual disease by MRI PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 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 no greater than 1.5 mg/dL AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal Creatinine less than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular No unstable angina No myocardial infarction within the past 6 months Other Cholesterol no greater than 350 mg/dL Triglycerides no greater than 400 mg/dL HIV negative Not immunocompromised No active autoimmune disorder No active infection requiring antibiotic therapy No other serious concurrent illness No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs No other major illness that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 3 weeks since prior immunotherapy No prior interferon alfa No other concurrent immunotherapy No prophylactic growth factors Concurrent epoetin alfa allowed Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy No prior CCI-779 No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed) Concurrent inhaled or replacement steroids allowed Radiotherapy At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery At least 3 weeks since prior surgery Other See Disease Characteristics At least 3 weeks since prior immunosuppressive agents At least 4 weeks since prior investigational agents No other concurrent investigational agents No concurrent immunosuppressive therapy No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide No concurrent maintenance therapy for life-threatening ventricular arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant interferon alfa|nan|
|Drug: temsirolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer