Lymphocyte Therapy in Treating Patients With Kidney Cancer
This trial is active, not recruiting.
|Treatments||aldesleukin, muromonab-cd3, therapeutic autologous lymphocytes, adjuvant therapy|
|Sponsor||National Cancer Institute (NCI)|
|Start date||July 1994|
|Trial size||90 participants|
|Trial identifier||NCT00002589, CDR0000063744, NCI-V94-0514, STLMC-BRM-9401|
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.
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
Male or female participants at least 16 years old.
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
|Official title||Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma|
|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.|
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