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Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
therapeutic autologous dendritic cells
conventional surgery
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
March 19, 2013
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005816
Brief Title
Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
Official Title
Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV kidney cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Vieweg, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12727829
Citation
Su Z, Dannull J, Heiser A, Yancey D, Pruitt S, Madden J, Coleman D, Niedzwiecki D, Gilboa E, Vieweg J. Immunological and clinical responses in metastatic renal cancer patients vaccinated with tumor RNA-transfected dendritic cells. Cancer Res. 2003 May 1;63(9):2127-33.
Results Reference
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Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer

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