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Preoperative Treatment With Cetuximab and/or IMC-A12

2014-07-23 21:13:39 | BioPortfolio

Summary

The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment. The safety of the study treatments will also be studied.

Primary Objectives:

The primary objective of this study is to assess the degree of modulation of phospho-AKT in Head and Neck Squamous Cell Carcinoma after a short, pre-operative course of treatment with cetuximab and/or IMC-A12.

Secondary Objectives:

The secondary objectives of this study are to assess:

1. Safety of cetuximab and/or IMC-A12 (particularly in the pre-operative setting),

2. Effects of IMC-A12 on glucose metabolism (with an emphasis on the pathophysiology of hyperglycemia).

3. Modulation of a panel of biomarkers in HNSCC after treatment with cetuximab and/or IMC-A12 and attempt correlation with clinical outcomes.

4. Objective response to, and histopathological changes after the short course of treatment.

Description

The Study Drugs:

Cetuximab and IMC-A12 are both designed to block proteins that are thought to cause cancer cells to grow. This may help to slow the growth of tumors.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. Within 30 days before you can receive the first study drug dose, 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:

- Your medical history will be recorded.

- You will have a physical exam.

- Your height, weight, body surface area, and vital signs (heart rate, blood pressure, and body temperature) will be measured.

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

- Blood (about 3 teaspoons ) will be drawn for routine tests.

- You will have a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head and neck to check the status of the disease.

Women who are able to become pregnant must have a negative pregnancy test before starting study treatment. For this test, urine will be collected or part of the routine blood sample will be used.

Tumor tissue will be tested to confirm your diagnosis and to test for biomarkers. If you already have enough leftover tumor tissue available from your last tumor biopsy, and that sample can be biomarker-tested, then the leftover tissue will be used. Otherwise, you will have a tumor biopsy performed.

The tumor biopsy will either be a CT-guided core biopsy or a punch biopsy.

- For a CT-guided core biopsy, a tumor tissue sample is withdrawn using a very thin needle and a syringe. The needle is guided while being viewed by the doctor on a CT scan.

- For a punch biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.

If the doctor thinks it is needed, you may have more than 1 tumor biopsy during screening.

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, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups. There is an equal chance of being assigned to any group.

- Group 1 will receive cetuximab alone.

- Group 2 will receive IMC-A12 alone.

- Group 3 will receive cetuximab and IMC-A12 in combination.

Study Treatment:

Groups 1 and 3:

Cetuximab will be given by vein on Days 1 and 8. The first dose will be given over 2 hours. The second dose will be given over 1 hour.

To lower the risk of allergic reaction, Groups 1 and 3 will also receive diphenhydramine by mouth or by vein before the first dose of cetuximab. If the study doctor decides it is needed, diphenhydramine may also be given before the second dose of cetuximab (and the third, if applicable).

Groups 2 and 3:

IMC-A12 will be given by vein over 1 hour on Days 1 and 8.

All Groups:

You will have surgery on Day 10. If for some reason the surgery is delayed, the study doctor may decide that you will receive a third dose of your assigned study drug(s) on Day 15. In that case, cetuximab will be given over 1 hour and/or IMC-A12 will be given over 1 hour, depending on which group you are in.

You will sign a separate consent form that describes the surgery and its risks in more detail.

Study Tests:

Within 5 days before your second dose of study drug(s), and again within 5 days before your third dose (if applicable), the following tests and procedures will be performed:

- Your medical history will be recorded.

- You will be asked about any side effects you may be experiencing.

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

- Blood (about 3 teaspoons) will be drawn for routine tests.

On the day before surgery, you will have a CT scan or MRI of the head and neck. If needed, these tests can instead be done before surgery but sometime after the last dose of the study drug(s).

On the day of surgery, blood (about 3 teaspoons) will be drawn for routine tests and your vital signs will be measured. If needed, these tests can instead be done up to 2 days before surgery.

Length of Study Drug Dosing:

After your last dose of the study drug(s), on Day 8 or Day 15, your participation in the study treatment period will be over. You will be taken off the study drug(s) early if the disease gets worse or intolerable side effects occur.

Follow-Up:

If you return to the clinic within 30 days after surgery, the following tests and procedures will be performed:

- Your medical history will be recorded.

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

- You will be asked about any side effects that may have occurred.

Otherwise if you do not have a visit scheduled during that time, the study staff will call you by phone instead. You will be asked how you are doing.

If you are experiencing side effects from the study drug(s) at the time of the follow-up visit or call, you may have additional follow-up if the doctor decides it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.

Long-Term Follow-Up:

On a long-time basis after surgery, the study staff may review your medical record to collect information about your health. During this time, you or your family members may be contacted and asked to confirm or provide information about your health. The contact may occur during clinic visits or by phone, mail, or e-mail.

This is an investigational study. Cetuximab is commercially available and FDA approved to treat squamous cell carcinoma that has spread or come back, in patients who did not respond to platinum-based therapy.

Using cetuximab in combination with surgery is investigational.

IMC-A12 is not FDA approved or commercially available. At this time, IMC-A12 is only being used in research. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Head and Neck Squamous Cell Carcinoma

Intervention

Cetuximab, IMC-A12, Surgical tumor resection

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:39-0400

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Medical and Biotech [MESH] Definitions

Unusual tumor affecting any site of the body, but most often encountered in the head and neck. Considerable debate has surrounded the histogenesis of this neoplasm; however, it is considered to be a myoblastoma of, usually, a benign nature. It affects women more often than men. When it develops beneath the epidermis or mucous membrane, it can lead to proliferation of the squamous cells and mimic squamous cell carcinoma.

The local implantation of tumor cells by contamination of instruments and surgical equipment during and after surgical resection, resulting in local growth of the cells and tumor formation.

A nuclear protein and tumor suppressor that contains a C-terminal PHD ZINC FINGER. It is expressed in different isoforms in various tissues and interacts with TUMOR SUPPRESSOR PROTEIN P53 to negatively regulate cell growth. Reduced expression and chromosomal rearrangements of the ING1 gene are associated with different cancers including HEAD AND NECK NEOPLASMS.

A tumor composed of cells resembling those of the hair matrix, which undergo 'mummification' and may calcify. It is a relatively uncommon tumor, which may occur at any age from infancy. The majority of patients are under 20, and females are affected more than males. The lesion is usually a solitary deep dermal or subcutaneous tumor 3-30 mm in diameter, situated in the head, neck, or upper extremity. (From Rook et al., Textbook of Dermatology, 4th ed, p2401)

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

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