Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma (NCT00387023) | Clinical Trial Compass
CompletedNot Applicable
Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma
United States12 participantsStarted 2004-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
What they're measuring
1
Number of Participants With Complete Response (CR) or Partial Response (PR)
✓. Female patients who are not pregnant or lactating
Exclusion criteria
✕. 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