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

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

Patrocinadores

Patrocinador principal: Agenus Inc.

Fuente Agenus Inc.
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio June 2000
Fecha de Terminación April 2007
Fecha de finalización primaria April 2007
Fase Phase 3
Tipo de estudio Interventional
Inscripción 650
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: autologous human tumor-derived HSPPC-96

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
| Anchorage, Alaska, United States
| Tucson, Arizona, United States
| Los Angeles, California, United States
| San Francisco, California, United States
| Denver, Colorado, United States
| Farmington, Connecticut, United States
| Boca Raton, Florida, United States
| Miami, Florida, United States
| Tampa, Florida, United States
| Atlanta, Georgia, United States
| Chicago, Illinois, United States
| Maywood, Illinois, United States
| Iowa City, Iowa, United States
| Kansas City, Kansas, United States
| Gretna, Louisiana, 70056, United States
| Baltimore, Maryland, 21287, United States
| Boston, Massachusetts, United States
| Rochester, Minnesota, 55905, United States
| St. Louis, Missouri, United States
| Albuquerque, New Mexico, United States
| Manhasset, New York, United States
| New York City, New York, United States
| Rochester, New York, United States
| Charlotte, North Carolina, United States
| Winston-Salem, North Carolina, United States
| Cincinatti, Ohio, United States
| Cleveland, Ohio, United States
| Columbus, Ohio, United States
| Eugene, Oregon, United States
| Portland, Oregon, United States
| Philadelphia, Pennsylvania, United States
| Knoxville, Tennessee, United States
| Nashville, Tennessee, United States
| Ft. Worth, Texas, United States
| Houston, Texas, United States
| South Burlington, Vermont, United States
| Richmond, Virginia, United States
| Seattle, Washington, United States
| Milwaukee, Wisconsin, United States
| Vienna, Austria
| Kortrijk, Belgium
| Liege, Belgium
| Calgary, Alberta, Canada
| Vancouver, British Columbia, Canada
| Victoria, British Columbia, Canada
| London, Ontario, Canada
| Toronto, Ontario, Canada
| Montreal, Quebec, Canada
| Quebec, Canada
| Lille, France
| Strasbourg, France
| Toulouse Cedex, France
| Villejuif Cedex, France
| Beer-Yaacob, Zerifin, Israel
| Haifa, Israel
| Holon, Israel
| Jerusalem, Israel
| Tel-Hashomer, Israel
| Oslo, Norway
| Stavanger, Norway
| Bialystok, Poland
| Gdansk, Poland
| Kielce, Poland
| Krakow, Poland
| Lublin, Poland
| Szczecin, Poland
| Warsaw, Poland
| Barcelona, Spain
| Madrid, Spain
| Valencia, Spain
| Gothenburg, Sweden
| Lund, Sweden
| Umea, Sweden
| Uppsala, Sweden
| Bristol, United Kingdom
| London, United Kingdom
Ubicacion Paises

Austria

Belgium

Canada

France

Israel

Norway

Poland

Spain

Sweden

United Kingdom

United States

Fecha de verificación

September 2012

Fiesta responsable

Tipo: Sponsor

Palabras clave
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov