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Study Summary
No. 2003-0696:.......Eye; Lymphoma......Bita Esmaeli......Ophthalmology/Head & Neck Surgery
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Study Summary Title
Study Summary
Number:
2003-0696
Study Title:Pilot trial of Radioimmunotherapy with Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva
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Physician New Patient Referral
Name:Bita EsmaeliPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Ophthalmology/Head & Neck SurgeryReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6920
Contact us about clinical trials
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General Information
Disease Group:Eye
Lymphoma
Supported By:N/A
Phase of Study:N/AReturn
Visit:
Participants should return to MDACC on a weekly to monthly basis.
Treatment
Agents:
90Y-ibritumomab tiuxetan
Rituxan
Rituximab
Zevalin
Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if giving Rituxan
(rituximab) and Zevalin may be effective in controlling orbital lymphoma
(cancer of the eye socket). The safety of treatment with Zevalin will also be
studied.
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Study Objectives / Outcomes
· To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or MALT of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
· To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
· To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.
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Study Status Information
Study Activation / Registration Date:02/02/2004
IRB Review and Approval Date:11/19/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 initiatiation, 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 recieve 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 determind 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 toxcities 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 treatment

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 diagnositic surgery, within four weeks

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Links
Registration Number: NCT00387023
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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