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Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas

90 Y Zevalin and rituximab are both designed to attach to lymphoma cells, causing them to

Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have a
physical exam. Blood (about 2 to 3 teaspoons) and urine will be collected for routine tests.
You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest,
abdomen (stomach area), and pelvis.

A PET scan is also recommended. A PET (Positron Emission Tomography) scan is a medical
technique that monitors the activity in the brain and other organs by tracking the movement
of a special radioactive solution through the body. The radioactive solution is either
inhaled as a mist or injected into a vein. The radioactive solution is usually made from
simple sugar that has radioactive particles attached to it. After the solution is injected
into a vein or inhaled, the PET scanner takes pictures of the radioactive solution as it
moves through the body and collects in various organs. By watching how the solution travels
through the body and studying where the solution collects, researchers can learn the extent
of disease in certain organs in the body.

You will have an electrocardiogram (ECG -- a test that measures the electrical activity of
the heart). You will have a bone marrow aspirate and biopsy performed. To collect a bone
marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and
a small amount of bone marrow and bone is withdrawn through a large needle. Women who are
able to have children must have a negative blood or urine pregnancy test.

If you are found to be eligible to take part in this study, you will be given
diphenhydramine (Benadryl) by vein and you will take acetaminophen (Tylenol) by mouth before
each dose of rituximab. This is done to help decrease the risk of developing side effects
of rituximab. You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day
1 of treatment. After treatment with rituximab, you will then be given 111 In Zevalin (this
is a radioactive agent that binds to rituximab to help with imaging exams), by vein over
about 10 minutes. This is so researchers can use a special camera to see where the drug is
in your body.

You will have imaging performed (on a camera, like an x-ray) on either Day 2 or 3. On Day 8
(7 days after the first dose of rituximab) you will receive a second dose of rituximab. You
will also be given Benadryl, Tylenol, and 90Y Zevalin in the same manner as on Day 1.

If you experience intolerable side effects while on this study, you may be removed from this
study. Your treatment on the study will end on Day 8.

You will return for follow-up tests for 4 years. Blood (about 2 tablespoons) will be drawn
weekly for the first 3 months. Blood (about 2 tablespoons each time) will also be drawn at
month 6 and 9 of the first year, and every 6 months in the second, third, and fourth years.
You may also have CT scans, PET scans (which are recommended), x-rays, and bone marrow
biopsies and aspirates performed, if your doctor thinks they are necessary.

Your participation on this study will end in about 4 years.

This is an investigational study. 90 Y Zevalin and rituximab are FDA approved and
commercially available. Their use in this study is investigational. Up to 36 patients will
take part in this multicenter study. Up to 36 patients will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin
lesions will be eligible provided that the skin is the only site of involvement.

2. Histology includes Indolent CD20+ lymphomas including: Follicular lymphoma,
Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/-
monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).

3. Signed Informed Consent.

4. Age >/= 18 years.

5. Pre-study Zubrod performance status of 0, 1, or 2.

6. Acceptable hematologic status within two weeks prior to patient registration,
including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC)
>/= 1, 500/mm^3, total lymphocyte count /=

7. Female patients who are not pregnant or lactating.

8. Men and women of reproductive potential who are following accepted birth control
methods (as determined by the treating physician, however abstinence is not an
acceptable method).

9. Patients determined to have < 25% bone marrow involvement with lymphoma within six
weeks of registration (define measurement of a bone marrow aspirate or biopsy).

10. Patient should have at least one lesion measuring >/= 1.5 cm in a single dimension.
Measurable cutaneous lesions are allowed.

Exclusion Criteria:

1. Presence of CNS lymphoma.

2. Patients with HIV or AIDS-related lymphoma.

3. Patients with pleural effusion.

4. Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.

5. Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.

6. Patients who have received prior external beam radiation therapy to > 25% of active
bone marrow (involved field or regional).

7. Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity

8. Serious nonmalignant disease or infection which, in the opinion of the investigator
and/or the sponsor, would compromise other protocol objectives.

9. Major surgery, other than diagnostic surgery, within four weeks.

10. Evidence of transformation in the latest biopsy.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

Evaulation one month following completion of treatment and performed by CT scan or MRI.

Safety Issue:


Principal Investigator

Felipe Samaniego, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Indolent Lymphomas
  • Ibritumomab Tiuxetan
  • Zevalin
  • Lymphoma



UT MD Anderson Cancer Center Houston, Texas  77030