Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Completed · Phase 2

Conditions studied: Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Lymphoma, Neurotoxicity, Radiation Toxicity

In brief

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill cancer cells. It is not yet know whether rituximab and combination chemotherapy are more effective when given with or without radiation therapy in treating patients with primary central nervous system lymphoma. PURPOSE: This randomized phase II trial studies how well giving rituximab and combination chemotherapy with or without radiation therapy works in treating patients with primary central nervous system lymphoma.

Key facts

Study ID

NCT01399372

Run by

Radiation Therapy Oncology Group

People needed

91

Starts

2011-09-01

Expected to finish

2022-05-20

Last updated by the study team

2023-07-20

Who can join

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

You may qualify if…

• B-cell non-Hodgkin's lymphoma(NHL) involving the brain, as demonstrated by contrast-enhanced Magnetic resonance imaging (MRI) and histologic confirmation by one of the following within 6 weeks prior to registration:
• A positive cerebral spinal fluid (CSF) cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
• A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma
• Brain biopsy
• Note: Patients in whom the type of lymphoma could not be determined or is unknown (eg, not enough tissue for further analysis) are assumed to have a B cell lymphoma and are eligible.
• The patient must agree to submit tissue (i.e., the original H/E stained slides and immunohistochemistry studies) for central pathology review post-registration.
• No evidence of systemic non-Hodgkin lymphoma as demonstrated by a computed tomography (CT) scan of the chest, abdomen and pelvis within 6 weeks prior to registration (Note: Bone marrow biopsy is not required for registration but must be obtained prior to start of treatment.)
• Age ≥ 18
• History and physical examination within 6 weeks of registration
• Karnofsky performance status (KPS) equal to 50 or higher, with the following exception
• Patients with KPS 30 to 50 are eligible if the reason for the poor performance status is neurologic deficit from primary central nervous system (CNS) lymphoma. (Patients with KPS 30 to 50 due to reasons other than primary CNS lymphoma are ineligible. Patients with KPS under 30 for any reason are ineligible)
• Patient must have documentation of negative HIV-1 testing within 6 weeks prior to study registration (Separate counseling and consent as per institutional guidelines)
• Complete blood count (CBC)/differential obtained within 2 weeks prior to study registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
• Platelets ≥ 100,000 cells/mm3;
• Hemoglobin (Hgb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
• Adequate liver function within 2 weeks prior to study registration, defined as follows:
• Bilirubin < 2.0 mg/dl
• Aspartate aminotransferase (AST) <2.5 times upper limit of normal
• Adequate renal function within 2 weeks prior to study registration, defined as follows
• Serum creatinine < 1.5 mg/dl
• Calculated creatinine clearance (CrCl) > 50cc/min/1.73m2, using the Cockcroft-Gault equation, as follows:
• Male: CrCl (ml/min) = (140-age) X (Actual weight in kg) / 72 x serum Creatinine (mg/dl).
• Female: CrCl (ml/min) = (140-age) X (Actual weight in kg) X 0.85 / 72 x serum Creatinine (mg/dl).
• Note: A measured CrCl from a 24 hour urine collection may also be used.

You may not qualify if…

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
• Prior treatment with chemotherapy or radiotherapy for lymphoma or chronic lymphocytic leukemia; note that prior chemotherapy for a different cancer is allowable; see section 1
• Prior cranial irradiation
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
• Known pre-existing immunodeficiency as seen in organ transplant recipient.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Prior allergic reaction to any of the study drugs involved in this protocol.

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Arizona Oncology-Deer Valley Center — Phoenix, Arizona, United States
• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States
• Fresno Cancer Center — Fresno, California, United States
• Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States
• Rohnert Park Cancer Center — Rohnert Park, California, United States
• The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States
• South Sacramento Cancer Center — Sacramento, California, United States
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
• Kaiser Permanente Cancer Treatment Center — South San Francisco, California, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Cadence Cancer Center in Warrenville — Warrenville, Illinois, United States
• Maine Medical Center-Bramhall Campus — Portland, Maine, United States
• Maine Medical Center- Scarborough Campus — Scarborough, Maine, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Nevada Cancer Research Foundation CCOP — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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