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Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA

Phase 1
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA

OBJECTIVES: I. Determine the maximum tolerated dose of autologous dendritic cells
transfected with autologous total tumor RNA in patients with stage III or IV renal cell
carcinoma. II. Assess the toxicity and feasibility of this treatment regimen in these
patients. III. Evaluate this regimen in terms of cellular immune response, clinical
response, and overall survival in these patients.

OUTLINE: This is a dose-escalation study. Patients undergo nephrectomy for tumor RNA
extraction followed by leukapheresis to collect peripheral blood mononuclear cells for
dendritic cell (DC) production. Patients receive autologous DC transfected with autologous
renal cell carcinoma RNA both IV and intradermally on weeks 0, 2, and 4. Cohorts of 3-6
patients receive escalating doses of DC IV until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then
every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study over 24 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV renal cell carcinoma
scheduled for resection of primary renal tumor No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 6 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 mg/dL
(transfusion independent) Platelet count at least 100,000/mm3 No history of bleeding
disorder or other blood dyscrasias Hepatic: Bilirubin less than 2.0 mg/dL PT less than 1.5
times control No serious hepatic disease Renal: Creatinine no greater than 2.5 mg/dL
Calcium less than 12 mg/dL No symptomatic hypercalcemia Cardiovascular: No serious cardiac
disease (e.g., New York Heart Association class III or IV heart disease) No deep vein
thrombosis Pulmonary: No serious pulmonary disease (e.g., asthma or chronic obstructive
pulmonary disease) No pulmonary embolism Other: No serious chronic or acute illness that
would preclude study No autoimmune disease (e.g., inflammatory bowel disease, systemic
lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or
multiple sclerosis) No psychological impediment that would preclude study No prior
malignancy within past 5 years except basal cell carcinoma, carcinoma in situ of the
cervix, nonmelanomatous skin cancer, controlled superficial bladder cancer, or surgically
or radiologically treated prostatic adenocarcinoma with no evidence of rising PSA for at
least 12 months after treatment No active acute or chronic infection (e.g., symptomatic
urinary tract infection, surgical site infection, or viral hepatitis) HIV negative Must
have adequate peripheral vein access Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy
(e.g., interleukin-2, interferon alfa, or autolymphocyte therapy) No other concurrent
immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy and recovered No
concurrent chemotherapy Endocrine therapy: At least 6 weeks since prior steroid therapy
and recovered No concurrent steroid therapy Radiotherapy: At least 6 weeks since prior
radiotherapy and recovered No concurrent local or palliative radiotherapy Surgery: See
Disease Characteristics At least 6 weeks since other prior major surgery and recovered No
prior radical nephrectomy Other: No concurrent immunosuppressive agents (e.g.,
azathioprine or cyclosporine)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Johannes Vieweg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2000

Completion Date:

August 2002

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Duke Comprehensive Cancer Center Durham, North Carolina  27710