Kidney Cancer
Conditions
Keywords
stage IV, renal cell carcinoma
Brief summary
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.
Detailed description
OBJECTIVES: * Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2. * Determine the immunogenicity of this regimen in these patients. * Determine the overall survival of patients treated with this regimen. * Determine the local and systemic toxicity of this regimen in these patients. OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis. At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks after the last dose of IL-2. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Interventions
BIOLOGICALInterleukin-2
BIOLOGICALB7-1
Sponsors
National Cancer Institute (NCI)
Chiron Corporation
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV renal cell carcinoma * Symptomatic primary tumor or resectable metastasis * Measurable disease post resection * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL * Hematocrit greater than 30% Hepatic: * Bilirubin less than 2 times normal * SGOT less than 3 times normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindications to surgical resection * No history of immunodeficiency disease * No known allergy to penicillin PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior interleukin-2, interferon alfa, or other biologic agent allowed Chemotherapy: * Not specified Endocrine therapy: * No concurrent corticosteroids (except for replacement doses for adrenal insufficiency) Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No concurrent immunosuppressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors | 4 years | The primary objective of this phase II trial involving 30 patients will be to determine tumor response rates. The immunogenicity of the treatment will be assessed by ELISPOT assays performed on the patients' peripheral blood lymphocytes, and by an immunohistochemical analysis of DTH skin tests site biopsies performed 48 hours after the intradermal injection of autologous, unmodified tumor cells. |
Countries
United States
Outcome results
None listed