Status:
COMPLETED
Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Biogen
Conditions:
Non-Hodgkin's Lymphoma
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 usi...
Detailed Description
Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell death. As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed to confirm...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00387023
Start Date
February 1 2004
End Date
July 1 2012
Last Update
November 18 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030