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A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Hodgkin's Lymphoma

Thank you

Trial Information

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.


Inclusion Criteria:



1. Relapsed or refractory classical Hodgkin lymphoma

2. Patients must have received a front-line standard anthracycline- containing regimen,
such as ABVD, Stanford V, or BEACOPP.

3. Bi-dimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single
dimension.

4. Patients must meet the following required baseline laboratory data: a) absolute
neutrophil count (ANC) >= 1,500/microL, b) platelet count >= 100,000/ microL, c)
hemoglobin >= 8 g/dL, d) serum bilirubin < 2.0 mg/dL, e) alkaline phosphatase < 2 x
upper limits of normal (ULN), f) AST and ALT < 2 x ULN, g) serum creatinine <= 1.5
mg/dL.

5. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
2.

6. Age >= 16 years.

7. Females of childbearing potential must have a negative serum beta-hCG pregnancy test
and must agree to use 2 highly effective contraceptive methods (hormonal
contraceptive, intra-uterine device, diaphragm with spermicide, condom with
spermicide, or abstinence) during the study and for 3 months after completion of
protocol treatment. Females of non-childbearing potential are those who are
postmenopausal for greater than 1 year or whom have had a bilateral tubal ligation or
hysterectomy.

8. Males who have partners of childbearing potential must agree to use an effective
contraceptive method during the study and for 3 months after completion of protocol
treatment.

9. Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

1. Lymphocyte predominant Hodgkin lymphoma histology.

2. More than one prior chemotherapy regimen.

3. Prior autologous or allogeneic stem cell transplant.

4. Presence of CNS involvement with Hodgkin lymphoma.

5. Known HIV infection or AIDS.

6. Active Hepatitis B or C infection or history of cirrhosis.

7. Grade 2 or greater peripheral neuropathy within 14 days of enrollment.

8. Hypersensitivity to boron or mannitol.

9. Prior bortezomib therapy.

10. Another primary malignancy (other than squamous cell and basal cell carcinoma of the
skin, in situ carcinoma of the cervix, or squamous intraepithelial lesion on PAP
smear, or treated prostate cancer with a stable PSA) for which the patient has not
been disease-free for at least 3 years.

11. Patients with congestive heart failure, Class III or IV, by New York Heart
Association (NYHA) criteria.

12. Patients with a myocardial infarction 6 months prior to enrollment, uncontrolled
angina, severe uncontrolled ventricular arrythmias , or ECG evidence of acute
ischemia or active conduction system abnormalities.

13. Patient with other medical or psychiatric illness that is likely to interfere with
participation in this clinical study.

14. Female subject that is pregnant or breast-feeding.

15. Patient that has received other investigational drugs within 14 days of enrollment.

16. Patients using concurrent therapy with corticosteroids at greater than or equal to 20
mg/day of prednisone equivalent.

17. Patients with active systemic bacterial, viral, or fungal infections that have
required IV antimicrobials within 4 weeks prior to protocol treatment.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Remission

Outcome Time Frame:

Evaluated for response after 0.75 months after receiving treatment for 3 cycles (21 days per cycle).

Safety Issue:

No

Principal Investigator

Michelle A. Fanale, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0604

NCT ID:

NCT00967369

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Hodgkin's Lymphoma
  • Lymphoma
  • Classical Hodgkin Lymphoma
  • Cancer
  • Bortezomib
  • Velcade
  • Chemotherapy
  • ICE
  • Ifosfamide
  • Ifex
  • Mesna
  • Mesnex
  • Carboplatin
  • Paraplatin
  • Etoposide
  • VePesid
  • BICE
  • Pegfilgrastim
  • Neulasta
  • Hodgkin Disease
  • Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030