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Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva

18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Lymphoma

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Trial Information

Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva

Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell

As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed
to confirm the diagnosis and status of the orbital lymphoma. The study doctors must first
make sure that the disease has not spread too much and is not severe enough to require
immediate treatment with chemotherapy before you can begin treatment on this study. You
will have about 4 teaspoons of blood drawn. Women who are able to have children must have a
negative blood or urine pregnancy test.

You will receive two injections of rituximab by vein over about 4 to 6 hours. This is
followed by an infusion of Zevalin over about 30 minutes on the same day. Whole body images
will be performed immediately and at 4-6, 24, 72, and 144 hours after receiving Zevalin.
About 1 week later, you will receive a second infusion of rituximab and Zevalin.

You may be taken off the study if your orbital lymphoma does not respond within three months
of receiving rituximab and Zevalin. Researchers will measure your response to therapy using
MRI of the orbit and an evaluation of the eye in the clinic. If you are taken off study,
you will be given the option of receiving external beam radiation therapy as treatment for
the disease.

Follow-up evaluations will be done every 3 months for 2 years and every 6 months for Years
3 and 4. This testing is considered standard of care and would include medical history,
physical exam, blood tests, and urine tests. The status of the disease will be evaluated
using CT scan or MRI of the orbit every 3 months for the first year and every 6 months for
Years 2, 3, and 4. Blood tests (about 4 teaspoons each) will be every 3 months for the
first year and may be continues every 3 to 6 month until they become negative or you start
another anti-cancer therapy.

This is an investigational study. Zevalin and rituximab are both FDA approved but their use
together in this study is investigational. A total of up to 12 patients will take part in
this study. All will be enrolled at M.D. Anderson.

Inclusion Criteria:

1. Biopsy-proven diagnosis of low-grade Non-Hodgkin's follicular lymphoma of the orbit
or MALT of the conjunctiva/orbit. The orbit/conjunctiva has to be the primary or
predominant site of involvement or if there is a previous history of systemic
involvement, the orbit/conjunctiva should be the only site of new recurrence.

2. No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or
Mitomycin C) prior to study initiation, and fully recovered from all toxicities
associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy

3. An IRB-approved signed informed consent

4. Age >18 years. This is justified since low-grade non-Hodgkin's lymphoma of the orbit
is extremely rare to non-existent in the pediatric population

5. Expected survival of >3 months

6. Pre-study performance status of 0, 1, or 2 according to the WHO

7. Acceptable hematologic status within two weeks prior to patient registration,
including: a) Absolute neutrophil count ([segmented neutrophils + bands] x total
WBC)> 1500/mm3 b) Total lymphocyte count < 5,000/mm3 for patients with small
lymphocytic lymphoma (IWFA) c) Platelet counts> 150,000/mm3, these patients will
receive a dose of 0.4 mCi/kg of Zevalin d) Platelet counts from 100,00/mm3 to
149,000/mm3, these patients will receive a 0.3mCi/kg dose of Zevalin

8. Female patients who are not pregnant or lactating

9. 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)

10. Patients previously on Phase II drugs are eligible if no long-term toxicity is
expected, and the patient has been off the drug for eight or more weeks with no
significant post treatment toxicities observed

11. Patients determined to have less than 25% bone marrow involvement with lymphoma
within six weeks of registration (based on a bone marrow biopsy). (This criteria must
be strictly met for adequate patient safety.)

Exclusion Criteria:

1. Patients with impaired bone marrow reserve, as indicated by one or more of the
following: a) Prior myeloablative therapies with autologous bone marrow
transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue b) Platelet count
< than 100,000 cells/mm3 c) Hypocellular bone marrow (less than 15% cellularity) d)
Marked reduction in bone marrow precursors of one or more cell lines (granulocytic,
megakaryocytic, erythroid)

2. Prior radioimmunotherapy

3. Presence of CNS lymphoma

4. Patients with HIV or AIDS-related lymphoma

5. Patients with small lymphocytic lymphoma (IWF A) - who have a total lymphocyte count
> 5,000/mm3

6. Patients with pleural effusion

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

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

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

10. Patients who have received G-CSF or GM-CSF therapy within two weeks prior to

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients with CR or PR Response

Outcome Description:

Tumor response to therapy based on clinical parameters and radiographically. At 3 months, tumor response classified as CR (complete response) or PR (partial response), or SD (stable disease), or PD (progressive disease).

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Bita Esmaeli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Orbital Lymphoma
  • Rituximab
  • Rituxan
  • Zevalin
  • Ibritumomab tiuxetan
  • IDEC-Y2B8
  • Eye
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



UT MD Anderson Cancer Center Houston, Texas  77030