A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
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.
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 of 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.
- You will have a chest x-ray and CT scans to check the status of the disease (Cycle 1
only).
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.
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 MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Remission
Evaluated for response after 0.75 months after receiving treatment for 3 cycles (21 days per cycle).
No
Michelle A. Fanale, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2008-0604
NCT00967369
August 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |