Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
16 Years
N/A
Both
Kidney Cancer
Trial Information
Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Survival as measured by Kaplan-Meier method at 5 years
Safety Issue:
No
Principal Investigator
John P. Hanson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Luke's Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000063744
NCT ID:
NCT00002589
Start Date:
July 1994
Completion Date:
Related Keywords:
- Kidney Cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
