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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033904
• Other study ID #: C-100-12 Part I
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2002
• Last updated: September 6, 2012
• Start date: June 2000
• Est. completion date: April 2007

Study information

• Verified date: September 2012
• Source: Agenus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• autologous human tumor-derived HSPPC-96

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Agenus, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Israel,  Norway,  Poland,  Spain,  Sweden,  United Kingdom,