Kidney Cancer
Conditions
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Brief summary
RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body. PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer.
Detailed description
OBJECTIVES: * Evaluate the ability of autologous lymphocyte therapy (ALT) given as adjuvant therapy following nephrectomy and/or complete surgical resection of any metastatic disease to delay or prevent metastatic recurrence in patients with high-risk renal cell carcinoma. * Determine the incidence of tumor recurrence and the survival of these patients treated with this regimen. * Determine the toxicity/morbidity of this regimen in these patients. * Explore the relationship between clinical response and in vitro autologous lymphocyte characteristics, including lytic activity, cytokine production, response to cytokines, and phenotypic profile in these patients treated with this regimen. * Assess patient immune status before, during, and after therapy. OUTLINE: Patients are stratified according to postnephrectomy interval (less than 3 months vs more than 3 months), extent of lymph node involvement (N1 vs N2-N3), interleukin-1 concentration in initial autologous lymphocyte culture (less than 500 pg/mL vs greater than 500 pg/mL), and prenephrectomy treatment. Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and monoclonal antibody OKT3. After cellular production, the autologous lymphocytes are reinfused over at least 30 minutes. Treatment repeats monthly for 6 months and then every 3 months for 6 months in the absence of unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years. PROJECTED ACCRUAL: A total of 10-90 patients will accrued for this study within 3 years.
Interventions
BIOLOGICALaldesleukin
BIOLOGICALmuromonab-CD3
BIOLOGICALtherapeutic autologous lymphocytes
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically documented and completely resected stage III or stage IV renal cell carcinoma, clinically staged within 2 months prior to initiation of therapy * No evidence of nephrotic syndrome PATIENT CHARACTERISTICS: Age: * Over 16 Performance status: * ECOG 0-2 Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count 50,000/mm3 to 500,000/mm\^3 * Hemoglobin at least 10 g/dL * No hematologic abnormalities Hepatic: * PT no greater than 1.5 times control * PTT less than 1.5 times control * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 4.0 mg/dL * Calcium no greater than 12 mg/dL * No symptomatic hypercalcemia Cardiovascular: * No uncontrolled or severe cardiac disease, e.g.: * No myocardial infarction within 6 months * No congestive heart failure Other: * HIV negative * No significant organ dysfunction * No other serious medical illness that would limit life expectancy * No significant CNS disease including uncontrolled or untreated psychiatric or seizure disorders * No uncontrolled bacterial, viral, or fungal infection * No active peptic or duodenal ulcer * Adequate peripheral venous access required * No prior malignancy within past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * No other concurrent postnephrectomy adjuvant therapy Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * More than 1 week since prior corticosteroids (except as inhalation therapy for respiratory ailments or replacement for adrenal insufficiency) * No concurrent therapy with the following: * Estrogens (except as postmenopausal replacement therapy) * Androgens * Progestins * Antiestrogens * Antiandrogens * LHRH analogues or antagonists * Other hormones Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior solid organ allograft * More than 3 weeks since major surgery, including nephrectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival as measured by Kaplan-Meier method at 5 years | — |
| Onset of recurrence as measured by Kaplan-Meier method at 5 years | — |
| Safety as measured by NCI Common Toxicity Criteria at completion of study | — |
Countries
United States
Outcome results
None listed