Trials Today

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

- Histologically proven primary CNS diffuse large b-cell lymphoma confirmed by one of
the following:

- Brain biopsy or resection

- Cerebrospinal fluid

- Vitreous fluid

- No prior organ transplantation to exclude post-transplant lymphoproliferative
disorders

- No prior chemotherapy or radiation therapy for lymphoma

- No prior allogeneic stem cell transplantation

- Use of systemic corticosteroids (dexamethasone up to 24 mg/day or equivalent) for
disease control or improvement of performance status to be tapered as fast as
clinically safe after initiation of therapy is permissible

- Not pregnant and not nursing, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and
newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic
effects. Therefore, female of childbearing potential (FCBP) must have a negative
serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of
human chorionic gonadotropin [HCG]) =< 7 days prior to registration

- Age >= 18 years

- Karnofsky performance scale (KPS) >= 40 (>= 50 for patients older than 60 unless
related to lymphoma on investigator's opinion)

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Calculated creatinine clearance >= 50 mL/min by Cockcroft-Gault formula

- Total Bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN)

- No evidence of non-Hodgkin's lymphoma (NHL) outside CNS

- No prior history of NHL

- No history of autoimmune disorder. Patients with active autoimmune disease or
history of autoimmune disease that might recur, which may affect vital organ
function or require immune suppressive treatment including systemic corticosteroids,
should be excluded. These include but are not limited to patients with a history of
immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating)
neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease
such as Systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma,
inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and
patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson
syndrome, or phospholipid syndrome should be excluded because of the risk of
recurrence or exacerbation of disease. Patients with vitiligo, endocrine
deficiencies including thyroiditis managed with replacement hormones including
physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and
other arthropathies, Sjogren's syndrome and psoriasis controlled with topical
medication and patients with positive serology, such as antinuclear antibodies
(ANA), anti-thyroid antibodies should be evaluated for the presence of target organ
involvement and potential need for systemic treatment but should otherwise be
eligible

- Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus,
residual hypothyroidism due to autoimmune condition only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected
to recur in the absence of an external trigger (precipitating event)

- Patients should be excluded if they have a condition requiring systemic treatment
with either corticosteroids (except short course of systemic corticosteroids for
disease control or improvement of performance status or other immunosuppressive
medications within 14 days prior to registration. Inhaled or topical steroids and
adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the
absence of active autoimmune disease. Patients are permitted to use topical, ocular,
intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic
absorption). Physiologic replacement doses of systemic corticosteroids are
permitted, even if < 10 mg/day prednisone equivalents. A brief course of
corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of
non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by
contact allergen) is permitted

- Patients who have had evidence of active or acute diverticulitis, intra-abdominal
abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are
known risk factors for bowel perforation should be evaluated for the potential need
for additional treatment before coming on study

- No prior or concurrent malignancies with exception of surgically cured carcinoma in
situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for >= 5
years

- No concurrent malignancy requiring active therapy

- No untreated hepatitis C virus (HCV) infection with detectable HCV viral load

- No untreated chronic hepatitis B virus (HBV) infection with detectable HBV viral
load

- No untreated human immunodeficiency virus (HIV) infection or with detectable viral
load or with CD4+T-cell count of less than 500/mm^3

- No history of HIV infection and evidence of Epstein Barr virus (EBV)-related primary
central nervous system lymphoma (PCNSL)

- Inability to tolerate anticoagulation with acetylsalicylic acid, warfarin, or direct
oral anticoagulants

- No other investigational agent

- No history of severe hypersensitivity reaction to any monoclonal antibody

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to or other agents used in study

- Sulfonamide drugs, trimethoprim, salicylates, nonsteroidal anti-inflammatory drugs,
penicillin, vitamin C, ciprofloxacin, and proton pump inhibitors should be held at
least 48 hours prior to methotrexate administration