Overview

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.