NCT00004880

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 advanced kidney cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 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

June 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

3.8 years

First QC Date

March 7, 2000

Last Update Submit

July 30, 2020

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Interventions

dendritic cell vaccine therapyBIOLOGICAL
conventional surgeryPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed metastatic renal cell carcinoma Evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm
  • Over 18
  • ECOG 0-1
  • Hematopoietic:
  • Hemoglobin at least 10 g/dL (not transfusion dependent)
  • Platelet count at least 75,000/mm3
  • WBC greater than 3,000/mm3
  • Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 5 times ULN
  • PT/PTT no greater than 1.5 times ULN
  • Bilirubin no greater than 2.5 mg/dL
  • Renal: Creatinine no greater than 2.0 g/dL
  • Hepatitis B surface antigen negative
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • +4 more criteria

You may not qualify if:

  • uncontrolled CNS metastasis
  • ischemic heart disease that precludes surgery
  • pulmonary condition that precludes surgery
  • other underlying condition or allergy that would preclude study
  • acute viral, bacterial, or fungal infection requiring therapy HIV negative
  • pregnant or nursing
  • other acute medical problems that would preclude study
  • concurrent corticosteroids (oral, topical, inhaled)
  • prior organ allografts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

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

  • Barbara J. Gitlitz, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 7, 2000

First Posted

May 20, 2004

Study Start

June 1, 1997

Primary Completion

April 1, 2001

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)