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Renal Cell CarcinomaPhase 3NCT00033904

Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer

A Phase 3 study testing autologous human tumor-derived HSPPC-96 in people with Renal Cell Carcinoma, run by Agenus Inc. at 76 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
autologous human tumor-derived HSPPC-96
How many people
650 participants
Where
76 sitesin 11 countries
Study dates
Jun 2000to Apr 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Pre-Surgery Inclusion Criteria:

  • Primary-intact resectable renal cell cancer, without known distant metastasis and be scheduled to have surgery with curative intent;
  • Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombus OR vena cava thrombus by radiologic evaluation
  • Performance status (Zubrod / ECOG-WHO scale)less than or equal to 1 and life expectancy of greater than three months, within 2 weeks of surgery.
  • Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of surgery.
  • Signed written informed consent.

Pre-Surgery Exclusion Criteria:

  • Prior chemo-, hormonal, immuno- or radiotherapy for renal cell cancer;
  • History of primary or secondary immunodeficiency, or patients using immunosuppressive drugs, e.g. systemic corticosteroids, cyclosporin A;
  • Current malignancies at other sites or previous other cancer within the last 5 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;
  • Known distant metastases;
  • Active, uncontrolled infection or other serious medical illnesses.

Eligibility Assessment:

(between 2 weeks pre- and 4 weeks post-surgery)

Prior to randomization and entry into the tumor evaluation phase, all subjects must undergo testing to confirm that they are free of distant metastatic disease, and that they meet all other criteria.

Eligibility Criteria which must be assessed and confirmed prior to randomization:

  • No evidence of metastatic or residual renal carcinoma as documented by all of the following: abdominal/pelvis CT scan; chest CT scan; and brain CT or MRI scan.
  • Provide Antigenics with greater than or equal to 7 grams of viable tumor tissue
  • Adequate bone marrow function.
  • Adequate renal and hepatic function.
  • Adequate cardiac function.
  • Signed written informed consent.
  • Patients must be willing to be followed during the course of tumor evaluation and follow-up phases.
  • Male or female patients of child producing potential must agree to use adequate contraception during the treatment/observation phase of the study.
  • Patients must not use any other investigational drug for four weeks prior to the start of the tumor evaluation phase and throughout the tumor evaluation phase of the study.

Trial locations and contacts

76 sites in 11 countries.

76 sites in 11 countries

United States39 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anchorage, Alaska

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Boca Raton, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Eugene, Oregon

  • Study site

    Farmington, Connecticut

  • Study site

    Fort Worth, Texas

  • Study site

    Gretna, Louisiana, 70056

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Kansas City, Kansas

  • Study site

    Knoxville, Tennessee

  • Study site

    Los Angeles, California

  • Study site

    Manhasset, New York

  • Study site

    Maywood, Illinois

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York

  • Study site

    San Francisco, California

  • Study site

    Seattle, Washington

  • Study site

    South Burlington, Vermont

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Canada7 sites

  • Study site

    Calgary, Alberta

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Gdansk

  • Study site

    Kielce

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Szczecin

  • Study site

    Warsaw

Other trials in Poland

Israel5 sites

  • Study site

    Beer-Yaacob, Zerifin

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Tel HaShomer

Other trials in Israel

France4 sites

  • Study site

    Lille

  • Study site

    Strasbourg

  • Study site

    Toulouse

  • Study site

    Villejuif

Other trials in France

Sweden4 sites

  • Study site

    Gothenburg

  • Study site

    Lund

  • Study site

    Umeå

  • Study site

    Uppsala

Other trials in Sweden

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Valencia

Other trials in Spain

Belgium2 sites

  • Study site

    Kortrijk

  • Study site

    Liège

Other trials in Belgium

Norway2 sites

  • Study site

    Oslo

  • Study site

    Stavanger

Other trials in Norway

United Kingdom2 sites

  • Study site

    Bristol

  • Study site

    London

Other trials in United Kingdom

Austria1 site

  • Study site

    Vienna

Other trials in Austria

About this study

Official title: A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Read the detailed description

Primary Objective:

  • The primary objective of this study is to determine whether subjects randomized to receive adjuvant HSPPC-96 after surgical resection of locally advanced renal cell carcinoma at high risk of recurrence, have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Secondary Objective:

  • Determine whether subjects randomized to receive HSPPC-96 have improved survival as compared to subjects with no adjuvant treatment.
  • Further characterize the safety profile of HSPPC-96.
Being tested
autologous human tumor-derived HSPPC-96
Keywords
Kidney Cancer, renal, immunotherapy, tumor,
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous human tumor-derived HSPPC-96Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2002 (estimated)
  2. Study startJun 2000
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
650 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033904
Sponsor's protocol ID
C-100-12 Part I
Status last verified
Sep 2012
First submitted
12 Apr 2002
Last updated
7 Sep 2012
Results posted
No

Publications

  • Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Hoos A, Teofilovici F, Isakov L, Flanigan R, Figlin R, Gupta R, Escudier B; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet. 2008 Jul 12;372(9633):145-154. doi: 10.1016/S0140-6736(08)60697-2. Epub 2008 Jul 3.

    PubMed 18602688

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing autologous human tumor-derived HSPPC-96 in people with Renal Cell Carcinoma, run by Agenus Inc. at 76 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada, Poland, Israel, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.

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