NCT00082459

Brief Summary

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2002

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

3.4 years

First QC Date

May 10, 2004

Last Update Submit

September 6, 2012

Conditions

Renal Cell Carcinoma

Keywords

Kidney CancerRenalTumorImmunotherapy

Interventions

autologous human tumor-derived HSPPC-96BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor
  • No previous therapy for metastatic renal cell carcinoma
  • Measurable disease (RECIST criteria)
  • Primary tumor greater than or equal to 7cm on CT or MRI
  • ECOG performance status 0-1
  • At least 18 years old
  • Life expectancy \> 3 months
  • Adequate cardiac function (NYHA I-II)
  • Not pregnant
  • Provide written informed consent
  • Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features)
  • Planned complete nephrectomy

You may not qualify if:

  • History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A
  • Other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin)
  • Embolization of the renal artery prior to nephrectomy
  • Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellKidney NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2004

First Posted

May 12, 2004

Study Start

July 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

US(1)