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Vitespen (HSPPC-96) for Immune Response Assessment Following Treatment of Resectable Renal Cell Carcinoma

2014-08-27 03:15:43 | BioPortfolio

Summary

The goal of this clinical research study is to learn if patients receiving HSPPC-96 after surgery have an immune response against kidney cancer and how long the immune system response may last.

Primary Objective:

- to determine whether patients exhibit a measurable immune response after multiple administrations of HSPPC-96, including evaluation of immune response after 12 weeks of treatment (corresponding to 8 doses of HSPPC-96) as assessed by ELISPOT assay.

Secondary Objectives:

- to assess if the immune response is durable beyond 12 weeks of treatment with the administration of 2 additional doses of HSPPC-96 or placebo at 6 and 12 months.

- to assess natural killer (NK) cell activity during the treatment with HSPPC-96.

- to assess safety following administration of HSPPC-96.

Description

The standard treatment for kidney cancer is surgery to remove the tumor with no further treatment after surgery. Normally patients are followed by their doctor through periodic check-ups, and in a number of patients the tumor will come back after a certain amount of time (this is referred to as "disease recurrence").

The Study Vaccine:

HSPPC-96 is a cancer vaccine. Vaccines attempt to produce a disease-fighting response in your body. HSPPC-96 is created using proteins in the tumor and is designed to reduce the risk of disease recurrence. In this study, the vaccine will be given after standard of care surgery.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

After your surgery, the tumor will be examined. In order for you to be able to take part in the study, the size of your tumor must be larger than about 2 inches.

Most of your tumor tissue will be sent to the sponsor. The sponsor must be able to make 8-10 doses of the vaccine from this tumor sample.

Within 6 weeks after your surgery, the following tests and procedures will be performed:

- You will have computed tomography (CT) and/or magnetic resonance imaging (MRI) scans of the chest and abdomen/pelvis to check the status of the disease.

- You will have a physical exam, including measurement of your height, weight, and vital signs (blood pressure, heart rate, temperature, and breathing rate).

- Blood (about 3 tablespoons) and urine will be collected for routine tests, to check your immune system for antibodies, and to tests for viruses, such as hepatitis and HIV.

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- Women who are able to become pregnant must have a negative blood or urine pregnancy test. If a blood pregnancy test is performed, a portion of your routine draw will be used.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in this study and the sponsor is able to make the vaccine, you will be assigned to Part 1a, Part 1b, or Part 2. Part 1a and Part 1b will enroll a total of 15 participants. Part 2 will enroll 20 patients.

Blood Draw/Leukapheresis:

About 6-7 weeks after surgery, blood (about 6 tablespoons) will be drawn to check the status of your immune system (the system in your body that prevents and fights illness).

If you are in Part 1b, you will have leukapheresis completed at this visit, rather than a regular immune status blood draw. Leukapheresis involves separating some of your white blood cells from your whole blood. The procedure involves drawing blood that is passed through a blood cell separator, a machine designed for collecting different parts of the blood.

Vaccine Administration:

You will receive HSPPC-96 injections into the skin in your upper arm, in the groin area, or below the collarbone. The injections will be given according to 1 of the schedules listed below. Eight (8) weeks after surgery is considered Week 1.

- For Part 1a participants, the vaccines will be given at Weeks 14-17, 19, 21, 23, and 25.

- For Part 1b and Part 2 participants, the vaccines will be given on Weeks 1-4, 6, 8, 10, and 12.

- Participants in Part 2 may receive the vaccine at Months 6 and 12.

Before and after the injection, your vital signs will be measured. If your vital signs after HSPPC-96 administrations are normal after each of your first four doses, your vital signs will not be collected after each additional dose. The area around the site of the injection will be checked for a reaction. You will also be asked about any side effects or physical complaints you may be feeling, any new medical conditions you may have, and any new drugs you may be taking.

Part 1 PROCEDURES:

If you are enrolled in Part 1a of the study, blood (about 6 tablespoons) will be drawn on Weeks 1, 3, 6, 8, 10, 12 and 14 to check your immune system.

-Blood (about 2 tablespoons) will be drawn for routine tests on Weeks 14, 17, 21, and 25.

If you are enrolled into study Part 1b, you will have leukapheresis performed on Week 10 to check your immune system.

- Blood (about 6 tablespoons) will be drawn on Weeks 1, 3, 6, 8, 12 and 14 to check your immune system.

- Blood (about 2 tablespoons) will be drawn on Weeks 1, 4, 8, and 12 for routine tests.

If you are enrolled in Part 1 (Part 1a or Part 1b), 6 and 12 months after study week 1, the following tests and procedures will be performed:

- You will be asked about any side effects or physical complaints you may be feeling, any new medical conditions you may have, and any new drugs you may be taking.

- You will have a CT scan to check the status of the disease.

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 3 tablespoons) and urine will be collected for routine tests and to check your immune system for antibodies.

- Your performance status will be recorded.

You will have a final safety visit if the disease returns while you are on study or 1 month after your last vaccine. At the final safety visit, the following tests and procedures will be performed:

- Blood (about 2 tablespoons) and urine will be collected for routine tests.

- Your weight and vital signs will be measured.

- You will be asked about any side effects or physical complaints you may be feeling, any new medical conditions you may have, and any new drugs you are taking.

Part 2 PROCEDURES:

If you are enrolled in study Part 2, blood (about 2 tablespoons) will be drawn for routine tests on Weeks 1, 4, 8, and 12.

Blood (about 6 tablespoons) will be drawn to check your immune system on Weeks 1, 3, 6, 8, 10, 12, and 14.

Once you have received 8 doses of HSPPC-96, you will be randomly assigned to either the "Treatment Extension Arm" or the "Placebo Extension Arm." The only difference between these 2 groups is what type of injection you will receive at the 6 and 12 month visits. Participants in the "Placebo Extension" group will receive a placebo injection. A placebo is a solution that looks like the study drug but has no active ingredients. Participants in the "Treatment Extension" group will receive HSPPC-96 injections at 6 and 12 months.

Within 1 week before and 2 weeks after each of these visits, blood (about 6 tablespoons) will be drawn to check your immune system.

At 6 and 12 months after your first dose, the following tests and procedures will be performed:

- You will be asked about any side effects or physical complaints you may be feeling, any new medical conditions you may have, and any new drugs you may be taking.

- You will have a CT scan to check the status of the disease.

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 3 tablespoons) and urine will be collected for routine tests and to check your immune system for antibodies.

- Your performance status will be recorded.

At Month 13, the following tests and procedures will be performed:

- You will be asked about any side effects or physical complaints you may be feeling, any new medical conditions you may have, and any new drugs you may be taking.

- Your vital signs will be measured.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- Urine will be collected for routine tests.

At Month 15, blood (about 6 tablespoons) will be drawn to check your immune system.

Length of Study:

You will remain in the study for a total of 15 months and will receive 8 or 10 doses of the study vaccine depending on the study group you belong to. You will be taken off treatment if the disease comes back, if you have intolerable side effects, or if your doctor thinks it is in your best interest.

Follow up:

Regardless of which part of the study you take part in, if the disease does return before the Month 12 visit, you will be contacted by phone, during a clinic visit, or by letter every 12 weeks through Month 15. If you complete the first 12 months on study without the disease returning, you will also be contacted at 15 months. You will be asked how you are and if you have had any additional therapy.

Additional Information:

- You must not use any other investigational drug for 4 weeks before you start the study and while you are in the study.

- After surgery, you also cannot take any drugs that affect the immune system. You must not to use any other cancer therapy while on study.

This is an investigational study. HSPPC-96 is not FDA approved or commercially available. HSPPC-96 is currently only being used in research in the United States.

Up to 55 patients will take part in this multicenter study. Up to 35 patients will be enrolled at M. D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

Vitespen (HSPPC-96), Vitespen (HSPPC-96)

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:43-0400

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Medical and Biotech [MESH] Definitions

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

The outer zone of the KIDNEY, beneath the capsule, consisting of KIDNEY GLOMERULUS; KIDNEY TUBULES, DISTAL; and KIDNEY TUBULES, PROXIMAL.

Long convoluted tubules in the nephrons. They collect filtrate from blood passing through the KIDNEY GLOMERULUS and process this filtrate into URINE. Each renal tubule consists of a BOWMAN CAPSULE; PROXIMAL KIDNEY TUBULE; LOOP OF HENLE; DISTAL KIDNEY TUBULE; and KIDNEY COLLECTING DUCT leading to the central cavity of the kidney (KIDNEY PELVIS) that connects to the URETER.

Stones in the KIDNEY, usually formed in the urine-collecting area of the kidney (KIDNEY PELVIS). Their sizes vary and most contains CALCIUM OXALATE.

Abnormal enlargement or swelling of a KIDNEY due to dilation of the KIDNEY CALICES and the KIDNEY PELVIS. It is often associated with obstruction of the URETER or chronic kidney diseases that prevents normal drainage of urine into the URINARY BLADDER.

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