Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor. The study is being conducted in Houston, Texas with patients enrolled into one of two treatment arms. The two treatment arms are either subcutaneous injection or intradermal injection, both with HSPPC-96. To be treated with HSPPC-96 patients must undergo surgery to remove the kidney tumor and a portion of this tissue will be sent to Antigenics' manufacturing facility for processing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Cell Carcinoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Kidney Cancer Renal Tumor Immunotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

autologous human tumor-derived HSPPC-96

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor
* No previous therapy for metastatic renal cell carcinoma
* Measurable disease (RECIST criteria)
* Primary tumor greater than or equal to 7cm on CT or MRI
* ECOG performance status 0-1
* At least 18 years old
* Life expectancy \> 3 months
* Adequate cardiac function (NYHA I-II)
* Not pregnant
* Provide written informed consent
* Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features)
* Planned complete nephrectomy

Exclusion Criteria

* History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A
* Other cancer (including renal cell carcinoma) within the last five 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
* Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-100-23

Identifier Type: -

Identifier Source: org_study_id