Clinical trial NCT00033904: Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Keywords: Kidney Cancer, renal, immunotherapy, tumor,
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2002-04-15
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Gretna
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Manhasset
country: United States
state: New York
city: New York City
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinatti
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: South Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Vienna
country: Austria
city: Kortrijk
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Lille
country: France
city: Strasbourg
country: France
city: Toulouse Cedex
country: France
city: Villejuif Cedex
country: France
city: Beer-Yaacob
country: Israel
state: Zerifin
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Tel-Hashomer
country: Israel
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Warsaw
country: Poland
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Gothenburg
country: Sweden
city: Lund
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Bristol
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References:
citation: 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.