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

Agenus

Status and phase

Terminated

Phase 3

Conditions

Kidney Cancer

Renal Cell Carcinoma

Treatments

Biological: HSPPC-96

Study type

Interventional

Funder types

Industry

Identifiers

NCT00126178

C-100-12 Part 2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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