Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer

Sponsor

Agenus Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00126178

Collaborator

(none)

600

Enrollment

Locations

Duration (Months)

85.7

Patients Per Site

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an international, open label, randomized phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with autologous HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer Renal Cell Carcinoma	Biological: HSPPC-96	Phase 3

Detailed Description

This is an international, open label, randomized Phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.

The primary objective of the study is to determine whether patients who receive adjuvant autologous HSPPC-96 (treatment group) after surgical resection of locally advanced renal cell carcinoma have improved recurrence-free survival as compared to patients who are not receiving adjuvant treatment (observation group). Eligible patients will have a 50% chance of receiving adjuvant treatment with HSPPC-96. Patients in the treatment arm of the trial will receive the vaccine once a week for 4 weeks, and then every other week until vaccine depletion or disease recurrence. Both groups of patients will be followed regularly for assessment of their disease status.

HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation) []

Secondary Outcome Measures

To determine whether patients randomized to receive adjuvant HSPPC-96 have improved overall survival as compared to patients in the observation group (without adjuvant treatment) []
To further characterize the safety profile of HSPPC-96 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

This does not represent the full set of inclusion/exclusion criteria

Inclusion Criteria:

Patients must have primary-intact resectable renal cell cancer, without distant metastasis and be scheduled to have surgery with curative intent
Tumor size > 5 cm OR macroscopic nodes OR vena cava thrombus by radiologic evaluation
At least 18 years old
Signed informed consent

Exclusion Criteria:

Prior surgery, chemo-, hormonal-, immuno-, or radiotherapy for kidney cancer
History of other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin
Current malignancies of any type in other sites
No active uncontrolled infection, other serious medical illnesses, or splenectomy
History of primary or secondary immunodeficiencies

Contacts and Locations

Locations

	City	State	Country
1	San Francisco	California	United States
2	Stanford	California	United States
3	Hackensack	New Jersey	United States
4	San Antonio	Texas	United States
5	South Burlington	Vermont	United States
6	Victoria	British Columbia	Canada
7	Toronto	Ontario	Canada