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

• Status: Completed
• Trial end date: 2003-11-01
• 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. 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.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Interferon-alpha; Interferons; Sirolimus

Criteria

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