Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the feasibility of treating relapsed follicular lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will receive EBRT (20 Gy in 10 fractions) followed by Bexxar.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: GlaxoSmithKline
• Treatments: Iodine; Iodine-131 anti-B1 antibody; Tositumomab I-131

Criteria

Inclusion Criteria

• Relapsed Stage I-IV (no evidence of bone marrow involvement) Follicular Non- Hodgkin's Lymphoma (NHF). Patients must have received at least 1 prior therapeutic regimen of chemotherapy or Rituximab and demonstrated progression as demonstrated by biopsy.

• One or more of the relapsed sites must be 5 cm or greater in dimension as assessed on two dimensional imaging from CT or MRI scan.

• Biopsy at time of relapse confirming continued presence of CD 20 positive follicular lymphoma.

• No anti-cancer therapy for 3 weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, chemotherapy, or immunotherapy.

• An IRB-approved signed informed consent.

• Expected survival rate greater than 3 months.

• Prestudy performance status of 0 or 1 according to the World Health Organization (WHO) criteria

• Acceptable hematologic status within two weeks prior to patient registration, including:

• Absolute neutrophil count (ANC) ([segmented neutrophils + bands] x total white blood cells) greater than 1,500/mm^3

• Platelet counts greater than 100,000/mm^3

• 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 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.

Exclusion Criteria

• Patients with impaired bone marrow reserve, as indicated by one or more of the following:

• Prior myeloablative therapies with bone marrow transplantation (either autologous or allogeneic) or peripheral blood stem cell (PBSC) rescue.

• Platelet count > 100,000 cells/mm^3

• Hypocellular bone marrow

• Marked reduction in bone marrow precursors of one or more cell lines (granulocytic,megakaryocytic, erythroid).

• History of failed stem cell collection

• Presence of bone marrow involvement with follicular lymphoma (FL) > 25% based on bone marrow biopsy done within 2 months of enrollment.

• Evidence of transformation from original FL to a more aggressive NHL histology.

• Prior radioimmunotherapy.

• All relapsed sites are < 5 cm in dimension as assessed on two dimensional imaging from CT or MRI scan.

• Presence of CNS (central nervous system) involvement.

• Presence of primary Non-Hodgkin Lymphoma (NHL) of bone.

• Patients with HIV or AIDS-related lymphoma.

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

• Patients who have received prior external beam radiation therapy within three months of registration.

• Patients who have received G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte-macrophage colony stimulating factor) 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.

• Presence of anti-murine antibody (HAMA) reactivity.