NCT00203866

Brief Summary

The purpose of this study is to determine whether the experimental vaccine G250 with or without IL-2 can produce an immune response in patients with renal cell carcinoma who have had all their cancer removed by surgery.

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 Oct 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

September 4, 2013

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • To determine whether immunization with G250 peptide/Montanide/GM-CSF plus IL-2 elicits a specific CTL response as assessed by ELISPOT.

Secondary Outcomes (1)

  • To explore differences in G250-specific CTL response as a function of IL-2 dose.

Interventions

G250 peptideDRUG
IL-2DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must express HLA-A2
  • Patients must have histologically or cytologically proven renal cell carcinoma that expresses G250 by IHC
  • Patients must have completely resected disease without any evidence of residual local or metastatic disease
  • Patients with resected locally advanced disease
  • Patients with metastatic disease(including synchronous metastatic site)
  • Patients with solitary metachronous metastatic disease
  • Age \>/=18 years
  • ECOG performance status 0-1
  • Patients must have normal organ and marrow function
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Patients who have had chemotherapy, radiotherapy, or an experimental (investigational) agent prior to starting treatment. Prior biologic therapy (IL-2 or interferon) is allowed only if it precedes a curative surgical therapy.
  • Patients may not have received a previous G250 vaccine.
  • Patients with residual metastatic disease following surgical resection are excluded from this clinical trial.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to G250, Montanide ISA-5 1, OM-CSF, or IL-2.
  • Patients must not have autoimmune disorders (SLE, Rheumatoid Arthritis), conditions of immunosuppression (such as HIV), or treatment with immunosuppressive drugs (including oral steroids, continuous use of topical steroids, steroid inhalers). Replacement doses of steroids for patients with adrenal insufficiency are allowed.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active GI bleeding, inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breast-feeding women
  • HIV-positive patients
  • Patients with a currently active second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Walter Stadler, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)