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Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

2014-08-27 03:19:44 | BioPortfolio

Summary

The goal of this clinical research study is to learn if bortezomib when given in combination with ifosfamide, carboplatin, and etoposide (a routine chemotherapy combination called ICE) can help to control Hodgkin's lymphoma better than ICE when given alone. The safety of this drug combination will also be studied.

Description

The Study Drugs:

Ifosfamide is designed to slow or stop the growth of cancer cells.

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.

Etoposide is designed to block cell growth.

Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die.

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. If you have had some of these tests or procedures performed recently, your study doctor may decide they do not need to be repeated. The following tests and procedures will be performed:

- Your medical history will be recorded and you will be asked about any other drugs that you may be taking.

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

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

- Blood (about 2 teaspoons) will be drawn for routine tests and to check for HIV and hepatitis B and C.

- You will have x-rays to check the status of the disease.

- If your doctor thinks it is needed, you will have a bone marrow biopsy to check the status of the disease. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

- You will have a chest x-ray and computed tomography (CT) scans of your abdomen, chest, and pelvis to check the status of the disease.

- You will have a positron emission tomography/computed tomography (PET/CT) scan to check the status of the disease.

- You will have either an echocardiogram or a multigated acquisition (MUGA) scan to test your heart function.

- Women who are able to become pregnant must have a negative blood (about 1 tablespoon) pregnancy test.

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 flip of a coin) to 1 of 2 groups:

- If you are in Group 1, you will receive bortezomib and ICE.

- If you are in Group 2, you will receive ICE only.

If you are one of the first 20 patients enrolled in this study, you will have an equal chance of being assigned to either group. If you join the study after 20 patients have been enrolled, you will have a higher chance of being assigned to the group that has been shown to be more effective.

Study Drug Administration:

Every "study cycle" will be made up of about 2 weeks. Cycles may need to be longer to allow for recovery.

You will need to stay in the hospital while you are receiving the study drugs. If you are in Group 1, you will need to be in the hospital for 5-7 days for this. If you are in Group 2, you will need to be in the hospital for 4-6 days for this.

You will receive ifosfamide by vein over 24 hours on Day 1 of each cycle. When you begin receiving ifosfamide, you will also begin receiving mesna by vein over 36 hours. Mesna is a drug that helps to protect the bladder from damage by ifosfamide.

You will receive carboplatin by vein over 1 hour on Day 1 of each cycle.

You will receive etoposide by vein over 2 hours each day on Days 1-3 of each cycle.

You will receive Neulasta (pegfilgrastim) through a needle under the skin on Day 5 (If you are in Group 1) or Day 4 (if you are in Group 2) of each cycle. Pegfilgrastim is a drug that helps low white blood cell counts return to normal levels.

If you are in Group 1, you will also receive bortezomib by vein over 5 seconds on Days 1 and 4 of each cycle.

Study Visits:

At all study visits, you will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.

Within 3 days before each cycle, the following tests and procedures will be performed:

- You will have a physical exam.

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

On each day that you receive study drugs, blood (about 2 teaspoons each time) will be drawn for routine tests.

One (1) time each week, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 21 (+/- 7 days) of Cycle 3, the following tests and procedures will be performed:

- You will have a physical exam.

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

- You will have a chest x-ray to check the status of the disease.

- You will have CT scans of the neck, chest, abdomen, and pelvis to check the status of the disease.

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

- You will have a bone marrow biopsy to check the status of the disease.

If you are found to be eligible to have a stem cell transplant after this visit, you will be taken off study. Your doctor will describe this procedure to you and you will sign a separate consent form.

Length of Study:

You can receive the study drugs for up to 6 cycles. You will be taken off study if you have intolerable side effects or if the disease gets worse.

End-of-Treatment Visit:

After you have finished receiving the study drugs for any reason, you will have an end-of-treatment visit. At the end-of-treatment visit, the following tests and procedures will be performed:

- You will have a physical exam.

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

- You will have a chest x-ray to check the status of the disease.

- You will have CT scans of the neck, chest, abdomen, and pelvis to check the status of the disease.

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

- If your doctor thinks it is needed, you will have a bone marrow biopsy to check the status of the disease.

Follow-Up Visits:

After the end-of-treatment visit, you will have follow-up visits every 4 months for 2 years. The following tests and procedures will be performed:

- You will have a physical exam.

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

- You will have a chest x-ray to check the status of the disease.

- You will have CT scans of the neck, chest, abdomen, and pelvis to check the status of the disease.

Additional Information:

- Taking other drugs and/or supplements may affect the way the study drugs work. Tell your study doctor about all drugs and/or supplements you are taking while you are on study.

- Tell your study doctor right away about any side effects you may be experiencing while on study. The study doctor may then give you other drugs to help ease possible side effects. Your study doctor will tell you more about these drugs.

This is an investigational study. Bortezomib is FDA approved and commercially available for the treatment of mantle cell lymphoma and myeloma. ICE is FDA approved and commercially available for the treatment of several types of lymphoma, including relapsed and refractory Hodgkins lymphoma. The combination of bortezomib and ICE for the treatment of Hodgkin's lymphoma is investigational.

Up to 50 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

Hodgkin's Lymphoma

Intervention

Bortezomib, Ifosfamide, Carboplatin, Etoposide, Neulasta (Pegfilgrastim), Mesna

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: 2014-08-27T03:19:44-0400

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Medical and Biotech [MESH] Definitions

A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.

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