Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
aldesleukin
+ muromonab-CD3
+ therapeutic autologous lymphocytes
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: July 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, United StatesOpen Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center in Google Maps