Kidney Cancer Clinical Trial
Lymphocyte Therapy in Treating Patients With Kidney Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Milwaukee Wisconsin, 53201, United States
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