Clinical trial NCT00126178: Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Kidney Cancer
Renal Cell Carcinoma
Keywords: Kidney Cancer
Renal
Immunotherapy
Vaccine
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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)
measure: To further characterize the safety profile of HSPPC-96
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Stanford
country: United States
state: California
city: Hackensack
country: United States
state: New Jersey
city: San Antonio
country: United States
state: Texas
city: South Burlington
country: United States
state: Vermont
city: Victoria
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
Study officials:
References: