Overview

Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunoglobulins
Rituximab
Criteria
Inclusion Criteria:

- The following histologic types by REAL classification and International Working
Formulation (IWF) when applicable (NOTE: Closed to accrual as of 10/29/07): Small
lymphocytic lymphoma; Lymphoplasmacytoid lymphoma; Follicular center lymphoma,
follicular grades 1, 2, and 3; Extranodal marginal zone B cell lymphoma of MALT type;
Nodal marginal zone B cell lymphoma

- The following histologic types by REAL classification and International Working
Formulation (IWF) when applicable: Diffuse large cell; Transformed lymphoma

- Less than 25% bone marrow involvement of cellular marrow with lymphoma as determined
by bilateral bone marrow aspirate and biopsy (the percent involvement should be
estimated by the hematopathologist using all of the biopsy material)

- There is no limit on the number of prior therapies (patients who have previously
received rituximab are eligible)

- Bi-dimensionally measurable disease: The patients must have >= 1 lesion that has a
single diameter of >= 2 cm

- Absolute neutrophil count >= 1500/mm^3

- Platelet count >= 150,000

- Total lymphocyte count < 5000/mm^3 only for patients with small lymphocytic lymphoma

- HGB >= 8

- Biopsy-proven relapsed, refractory, or residual CD20+ non-Hodgkin's lymphomas;
previous biopsies =<6 months prior to treatment on this protocol will be acceptable as
long as there has not been intervening therapy; if the patient has received therapy
for NHL between the time of the last biopsy and this protocol, then a re-biopsy is
necessary

- ECOG performance status (PS) 0, 1, or 2

- Expected survival >= 3 months

- Willingness to provide all biologic specimens as required by the protocol

- Total bilirubin =< 2 x ULN mg/dL (if abnormal, direct bilirubin =< 1.5 x ULN)

Exclusion Criteria:

- Prior myeloablative therapies with autologous or allogeneic bone marrow
transplantation or peripheral blood stem cell support

- Prior radioimmunotherapy including Y-90 Zevalin or 131-Iodine anti-B1 antibody or
Lym-1

- Presence of CNS lymphoma

- Serious non-malignant disease such as active infection or other condition which in the
opinion of the investigator would compromise other protocol objectives

- Major surgery other than diagnostic surgery =< 4 weeks prior to registration

- Another active primary malignancy

- Known HAMA/HACA (Human anti-mouse or anti-chimeric antibodies)

- Myelodysplastic syndrome or marrow chromosomal changes suggesting myelodysplasia

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception (condoms, diaphragm, birth control pills, injections, intrauterine
device [IUD], surgical sterilization, abstinence, etc.)

- Failed stem cell collection

- Marrow cellularity =< 15% (as determined on all bone marrow samples)

- Known to have lymphoma related to HIV or AIDS (these patients are excluded because it
is unknown what effects prolonged B-cell depletion will have on these patient's immune
system)

- G-CSF or GM-CSF therapy =< 1 week prior to study registration (pegylated filgrastim =<
3 weeks)

- Myelosuppressive chemotherapy =< 3 weeks prior to study registration (=< 6 weeks if
rituximab, nitrosourea, or Mitomycin C)

- Skin rash (such as Stevens-Johnson's syndrome or toxic epidermal necrolysis) with
prior rituximab therapy should not be entered on this study because of the risk of
reoccurrence of that skin toxicity

- Abnormal renal function (serum creatinine > 2 mg/dL)

- Pre-existent clinical autoimmune or antibody mediated diseases, including systemic
lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and
autoimmune thrombocytopenia (patients that have no clinical symptoms of these
diseases, but merely have previously detected antibodies are eligible)

- Received prior external beam radiation therapy to > 25% of active bone marrow

- Corticosteroid therapy at the time the patient enters the protocol; patients using
prednisone or its equivalent for adrenal failure or using < 20mg of prednisone/day for
other benign causes are accepted