Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma

Completed · Not applicable

Conditions studied: Non-Hodgkin's Lymphoma, Lymphoma

In brief

Primary Objectives: 1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible. 2. 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. 3. To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.

Key facts

Study ID: NCT00387023
Run by: M.D. Anderson Cancer Center
People needed: 12
Starts: 2004-02-01
Expected to finish: 2012-07-01
Last updated by the study team: 2013-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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
An Institutional Review Board (IRB)-approved signed informed consent
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
Expected survival of >3 months
Pre-study performance status of 0, 1, or 2 according to the WHO
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
Female patients who are not pregnant or lactating
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)
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
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.)

You may not qualify if…

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)
Prior radioimmunotherapy
Presence of central nervous system (CNS) lymphoma
Patients with HIV or AIDS-related lymphoma
Patients with small lymphocytic lymphoma (IWF A) - who have a total lymphocyte count > 5,000/mm3
Patients with pleural effusion
Patients with abnormal liver function: total bilirubin > 2.0 mg/dL
Patients with abnormal renal function: serum creatinine > 2.0 mg/dL
Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
Patients who have received Granulocyte colony-stimulating factor (G-CSF or GM-CSF) therapy within two weeks prior to treatment
Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
Major surgery, other than diagnostic surgery, within four weeks

Where it is running

UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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