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Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
This study has been completed.
Sponsored by: Antigenics
Information provided by: Antigenics
ClinicalTrials.gov Identifier: NCT00033904
  Purpose

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 Intervention Phase
Renal Cell Carcinoma
Drug: autologous human tumor-derived HSPPC-96
Phase III

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Oncophage
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy 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

Further study details as provided by Antigenics:

Estimated Enrollment: 650
Study Start Date: June 2000
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033904

  Show 76 Study Locations
Sponsors and Collaborators
Antigenics
  More Information

Click here for more information about Oncophage (HSPPC-96)  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Study ID Numbers: C-100-12 Part I
Study First Received: April 12, 2002
Last Updated: July 11, 2007
ClinicalTrials.gov Identifier: NCT00033904  
Health Authority: United States: Food and Drug Administration

Keywords provided by Antigenics:
Kidney Cancer, renal, immunotherapy, tumor,

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009