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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033904
Recruitment Status : Completed
First Posted : April 15, 2002
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Agenus Inc.

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: autologous human tumor-derived HSPPC-96 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2000
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033904

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Sponsors and Collaborators
Agenus Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Agenus Inc. Identifier: NCT00033904     History of Changes
Other Study ID Numbers: C-100-12 Part I
First Posted: April 15, 2002    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

Keywords provided by Agenus Inc.:
Kidney Cancer, renal, immunotherapy, tumor,

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases