NCT00005816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
Last Updated

March 20, 2013

Status Verified

December 1, 2008

First QC Date

June 2, 2000

Last Update Submit

March 19, 2013

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancer

Interventions

therapeutic autologous dendritic cellsBIOLOGICAL
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 12727829RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Johannes Vieweg, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

March 23, 2004

Study Start

February 1, 2000

Study Completion

August 1, 2002

Last Updated

March 20, 2013

Record last verified: 2008-12

Locations

US(1)