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

Stopped early · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT00475332

Run by

University of Florida

People needed

2

Starts

2007-09-01

Expected to finish

2009-04-01

Last updated by the study team

2012-02-15

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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